Gastroenterology, Urology

Page 2 of 3

Code	Device name	Class	21 CFR	510(k) (3y)
FIW	Alarm, Pillow Pressure	Class 2	21 CFR 876.5820	1
FIZ	Meter, Conductivity, Non-Remote	Class 2	21 CFR 876.5820	13
FJA	Manometer, Water	Class 2	21 CFR 876.5820
FJB	Detector, Dialysate Level	Class 2	21 CFR 876.5820	3
FJC	Detector, Blood Level	Class 2	21 CFR 876.5820	1
FJD	Detector, Leak, Blood	Class 2	21 CFR 876.5820	4
FJF	Detector, Air Bubble	Class 2	21 CFR 876.5820	5
FJG	Dialyzer, Parallel Flow	Class 2	21 CFR 876.5820	36
FJH	Dialyzer, Disposable	Class 2	21 CFR 876.5830	4
FJI	Dialyzer, Capillary, Hollow Fiber	Class 2	21 CFR 876.5820	131
FJJ	Dialyzer, Twin Coil	Class 2	21 CFR 876.5820
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Class 2	21 CFR 876.5820	77
FJL	Resectoscope	Class 2	21 CFR 876.1500	24
FJM	Guard, Shunt	Class 2	21 CFR 876.5540
FJN	Stabilizer, Shunt	Class 2	21 CFR 876.5540
FJO	Plier, Tube	Class 1	21 CFR 876.5540
FJP	Adaptor, Y	Class 2	21 CFR 876.5820
FJQ	Connector, Shunt	Class 1	21 CFR 876.5540	3
FJR	Forceps, Disconnect	Class 1	21 CFR 876.5540
FJS	Catheter, Peritoneal, Long-Term Indwelling	Class 2	21 CFR 876.5630	48
FJT	Intracatheter, Dialysis	Class 2	21 CFR 876.5820	5
FJW	Ring, Joint	Class 1	21 CFR 876.5540
FJX	Ring, Crimp	Class 1	21 CFR 876.5540
FJY	Plier, Crimp	Class 1	21 CFR 876.5540
FJZ	Declotting Tray, Kit (Including Contents)	Class 2	21 CFR 876.5820	3
FKA	Dilator, Vessel	Class 2	21 CFR 876.5540	3
FKB	Connector, Blood Tubing, Infusion T	Class 2	21 CFR 876.5820	2
FKC	Clamp, Cannula	Class 1	21 CFR 876.5540	1
FKD	Canister, Coil	Class 2	21 CFR 876.5820	1
FKE	Tie, Dialysis	Class 1	21 CFR 876.5820
FKF	Gun, Tie, Dialysis	Class 1	21 CFR 876.5820
FKG	Tray, Start/Stop (Including Contents), Dialysis	Class 1	21 CFR 876.5820	6
FKH	Solution-Test Standard-Conductivity, Dialysis	Class 2	21 CFR 876.5820	8
FKI	Set, Dialyzer Holder	Class 2	21 CFR 876.5820	3
FKJ	Filter, Blood, Dialysis	Class 2	21 CFR 876.5820	5
FKK	Clamp, Line	Class 1	21 CFR 876.4730	6
FKL	Insert, Pump, Blood	Class 2	21 CFR 876.5820	1
FKM	Adaptor, Fistula	Class 2	21 CFR 876.5820
FKN	Adaptor, Shunt	Class 2	21 CFR 876.5540	4
FKO	Catheter, Peritoneal Dialysis, Single Use	Class 2	21 CFR 876.5630	16
FKP	System, Dialysate Delivery, Single Patient	Class 2	21 CFR 876.5820	50
FKQ	System, Dialysate Delivery, Central Multiple Patient	Class 2	21 CFR 876.5820	61
FKR	Subsystem, Proportioning	Class 2	21 CFR 876.5820	12
FKT	System, Dialysate Delivery, Sorbent Regenerated	Class 2	21 CFR 876.5600	19
FKW	Tip, Vessel	Class 2	21 CFR 876.5540	3
FKX	System, Peritoneal, Automatic Delivery	Class 2	21 CFR 876.5630	83
FKY	Connector, Tubing, Dialysate	Class 2	21 CFR 876.5820	4
FLA	Monitor, Temperature, Dialysis	Class 2	21 CFR 876.5820	3
FLB	Meter, Conductivity, Induction, Remote Type	Class 2	21 CFR 876.5820	6
FLC	Station, Dialysis Control, Negative Pressure Type	Class 2	21 CFR 876.5820	4
FLD	Apparatus, Hemoperfusion, Sorbent	Class 2	21 CFR 876.5870	11
FOC	Bag, Urine Collection, Newborn	Class 2	21 CFR 876.5250	4
FON	Bag, Drainage, With Adhesive, Ostomy	Class 1	21 CFR 876.5900	3
FPD	Tube, Feeding	Class 2	21 CFR 876.5980	59
FRQ	Tube, Levine	Class 2	21 CFR 876.5980	3
FTI	Lamp, Endoscope, Incandescent	Class 2	21 CFR 876.1500	2
FTJ	Colonoscope, General & Plastic Surgery	Class 2	21 CFR 876.1500
FTO	Prosthesis, Testicle	Class 3	21 CFR 876.3750
FTQ	Prosthesis, Penis, Rigid Rod	Class 2	21 CFR 876.3630	2
GBL	Catheter, Ureteral, General & Plastic Surgery	Class N	21 CFR 876.5130
GBM	Catheter, Urethral	Class 2	21 CFR 876.5130	71
GBT	Catheter, Rectal	Class 2	21 CFR 876.5980	3
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation	Class 2	21 CFR 876.5010	26
GCF	Proctoscope	Class 2	21 CFR 876.1500	2
GCG	Peritoneoscope	Class 2	21 CFR 876.1500
GCH	Mediastinoscope, Diagnostic	Class 2	21 CFR 876.1500
GCI	Laryngoscope, Endoscope	Class 2	21 CFR 876.1500	14
GCJ	Laparoscope, General & Plastic Surgery	Class 2	21 CFR 876.1500	1428
GCK	Gastroscope, General & Plastic Surgery	Class 2	21 CFR 876.1500
GCL	Esophagoscope, General & Plastic Surgery	Class 2	21 CFR 876.1500	4
GCM	Endoscope, Rigid	Class 2	21 CFR 876.1500	18
GCN	Endoscope, Prism	Class 2	21 CFR 876.1500
GCO	Endoscope, Mirror	Class 2	21 CFR 876.1500	3
GCP	Endoscope, Ac-Powered And Accessories	Class 2	21 CFR 876.1500	13
GCQ	Endoscope, Flexible	Class 2	21 CFR 876.1500	5
GCS	Endoscope, Battery-Powered And Accessories	Class 2	21 CFR 876.1500	9
GCT	Light Source, Endoscope, Xenon Arc	Class 2	21 CFR 876.1500	47
GCW	Transformer, Endoscope	Class 2	21 CFR 876.1500	1
GDB	Endoscope, Fiber Optic	Class 2	21 CFR 876.1500	7
GDS	Bag, Stomal	Class 1	21 CFR 876.5900	2
JCW	Prosthesis, Penis, Inflatable	Class 3	21 CFR 876.3350
KDH	Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration	Class 2	21 CFR 876.5980	23
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Class 2	21 CFR 876.5860	345
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Class 2	21 CFR 876.5630	113
KDK	Container, Transport, Kidney	Class 2	21 CFR 876.5880	3
KDL	Set, Perfusion, Kidney, Disposable	Class 2	21 CFR 876.5880	19
KDM	Sigmoidoscope, Rigid, Non-Electrical	Class 2	21 CFR 876.1500	1
KDN	System, Perfusion, Kidney	Class 2	21 CFR 876.5880	44
KDO	Rongeur, Cystoscopic, Hot	Class 2	21 CFR 876.1500	1
KGC	Tube, Gastro-Enterostomy	Class 2	21 CFR 876.5980	26
KGD	Scissors For Cystoscope	Class 2	21 CFR 876.1500	2
KGE	Forceps, Biopsy, Electric	Class 2	21 CFR 876.4300	46
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Class 2	21 CFR 876.1725	31
KNQ	Dilator, Esophageal	Class 2	21 CFR 876.5365	40
KNR	Adapter, A-V Shunt Or Fistula	Class 2	21 CFR 876.5540	1
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Class 2	21 CFR 876.4300	188
KNT	Tubes, Gastrointestinal (And Accessories)	Class 2	21 CFR 876.5980	651
KNW	Instrument, Biopsy	Class 2	21 CFR 876.1075	365
KNX	Collector, Urine, (And Accessories) For Indwelling Catheter	Class 2	21 CFR 876.5250	206
KNY	Accessories, Catheter, G-U	Class 2	21 CFR 876.5130	65
KNZ	Accessories, A-V Shunt	Class 2	21 CFR 876.5540	10
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Class 1	21 CFR 876.4730	44
KOB	Catheter, Suprapubic (And Accessories)	Class 2	21 CFR 876.5090	32
KOC	Accessories, Blood Circuit, Hemodialysis	Class 2	21 CFR 876.5820	182
KOD	Catheter, Urological	Class 2	21 CFR 876.5130	238
KOE	Dilator, Urethral	Class 2	21 CFR 876.5520	27
KPF	System, Dialysate Delivery, Semi-Automatic, Peritoneal	Class 2	21 CFR 876.5630	13
KPH	Catheter, Rectal For Continent Ileostomy	Class 1	21 CFR 876.5030	1
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Class 2	21 CFR 876.5320	96
KPL	Colonic Irrigation System	Class 2	21 CFR 876.5220	40
KPM	Shunt, Peritoneal	Class 2	21 CFR 876.5955	19
KPN	Alarm, Conditioned Response Enuresis	Class 2	21 CFR 876.2040	37
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Class 2	21 CFR 876.5820	124
KPP	Peritoneal Dialysate Filter	Class 2	21 CFR 876.5630	3
KQQ	Tubing, Dialysate (And Connector)	Class 2	21 CFR 876.5820	1
KQR	Detector, Air Or Foam	Class 2	21 CFR 876.5820
KQS	Table, Cystometric, Non-Electric And Accessories	Class 1	21 CFR 876.4890	8
KQT	Evacuator, Gastro-Urology	Class 2	21 CFR 876.4370	14
KXM	System Accessories, Extracorporeal	Class 2	21 CFR 876.5820	4
KYH	Endoscope, Ophthalmic	Class 2	21 CFR 876.1500	1
LBW	Set, Dialysis, Single Needle (Co-Axial Flow)	Class 2	21 CFR 876.5540	5
LCG	Intestinal Splinting Tubes	Class 2	21 CFR 876.5980
LEY	Set, Oral Administration	Class 2	21 CFR 876.5980	1
LFJ	Catheter, Subclavian	Class 2	21 CFR 876.5540	65
LFK	Catheter, Femoral	Class 2	21 CFR 876.5540	16
LIF	Dialyzer Reprocessing System	Class 2	21 CFR 876.5820	57
LJH	System, Irrigation, Urological	Class 2	21 CFR 876.5130	28
LKY	Device, External Penile Rigidity	Class 2	21 CFR 876.5020	87
LLB	System, Blood, Extracorporeal And Accessories	Class 2	21 CFR 876.5820	2
LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Class 2	21 CFR 876.5990	56
LQC	Lithotriptor, Biliary Mechanical	Class 2	21 CFR 876.4500	11
LQR	Dislodger, Stone, Biliary	Class 2	21 CFR 876.5010	38
LRI	Ph Meter For Dialysis Hydrogen Ion Concentration	Class 2	21 CFR 876.5820	1
LYK	Angioscope	Class 2	21 CFR 876.1500	41
MFJ	Device, Endoscopic Suturing	Class 2	21 CFR 876.1500	1
MJC	Catheter, Urological (Antimicrobial) And Accessories	Class 2	21 CFR 876.5130	10
MLW	Warmer, Peritoneal Dialysate	Class 2	21 CFR 876.5630	6
MMZ	Table, Cystometric, Electric	Class 2	21 CFR 876.4890	4
MND	Ligator, Esophageal	Class 2	21 CFR 876.4400	15
MNG	External Urethral Occluder, Urinary Incontinence-Control, Female	Class 1	21 CFR 876.5160	7
MNK	Endoscopic Bite Block	Class 1	21 CFR 876.1500	6
MNL	Accessories, Cleaning Brushes, For Endoscope	Class 1	21 CFR 876.1500	4
MNV	Strip, Dialysate Ph Indicator	Class 2	21 CFR 876.5820	6
MON	System, Hemodialysis, Remote Accessories	Class 1	21 CFR 876.5820
MPA	Endoilluminator	Class 2	21 CFR 876.1500	41
MPB	Catheter, Hemodialysis, Non-Implanted	Class 2	21 CFR 876.5540	38
MQS	System, Hemodialysis, Access Recirculation Monitoring	Class 2	21 CFR 876.5820	18
MSB	System And Accessories, Isolated Heart, Transport And Preservation	Class 2	21 CFR 876.5880	13
MSD	Catheter, Hemodialysis, Implanted	Class 2	21 CFR 876.5540	124
MSE	Hemodialyzer, Re-Use, Low Flux	Class 2	21 CFR 876.5820	7
MSF	Hemodialyzer, Re-Use, High Flux	Class 2	21 CFR 876.5860	8
MSY	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant	Class 2	21 CFR 876.5665	13
MSZ	Strip, Test, Reagent, Residuals For Dialysate	Class 2	21 CFR 876.5665
MYE	System, Electrogastrography (Egg)	Class 2	21 CFR 876.1735	8
NAM	Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence	Class 2	21 CFR 876.5310	8
NAY	System, Surgical, Computer Controlled Instrument	Class 2	21 CFR 876.1500	165
NBG	Marker, Colon	Class 2	21 CFR 876.1500	2
NDS	Media, Culture, Ex Vivo, Tissue And Cell	Class 2	21 CFR 876.5885	9
NEQ	Device, Telemedicine, Robotic	Class 2	21 CFR 876.1500	2
NEZ	System, Imaging, Gastrointestinal, Wireless, Capsule	Class 2	21 CFR 876.1300	47
NFK	Kit, Repair, Catheter, Hemodialysis	Class 2	21 CFR 876.5540	11
NGU	Balloon, Liver Tamponade	Class 2	21 CFR 876.5980	1
NHV	System, Water Purification, General Medical Use	Class 2	21 CFR 876.5665	11
NIE	Catheter, Hemodialysis, Triple Lumen, Non-Implanted	Class 2	21 CFR 876.5540	12
NIF	Catheter, Hemodialysis, Triple Lumen, Implanted	Class 2	21 CFR 876.5540
NIH	Disinfectant, Subsystem, Water Purification	Class 2	21 CFR 876.5665	1
NII	Disinfectant, Dialysate Delivery System	Class 2	21 CFR 876.5860	2
NKZ	Endoilluminator, Reprocessed	Class 2	21 CFR 876.1500
NLM	Laparoscope, General & Plastic Surgery, Reprocessed	Class 2	21 CFR 876.1500	23
NLR	Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Repro	Class 2	21 CFR 876.4300	1
NLS	Instrument, Biopsy, Reprocessed	Class 2	21 CFR 876.1075
NLT	Snare, Flexible, Reprocessed	Class 2	21 CFR 876.4300
NLU	Forceps, Biopsy, Electric, Reprocessed	Class 2	21 CFR 876.4300	4
NLV	Electrode, Flexible Suction Coagulator, Reprocessed	Class 2	21 CFR 876.4300
NLW	Electrode, Electrosurgical, Active, Urological, Reprocessed	Class 2	21 CFR 876.4300	1
NLX	Needle, Pneumoperitoneum, Spring Loaded, Reprocessed	Class 2	21 CFR 876.1500
NML	Catheter, Biliary, Reprocessed	Class 2	21 CFR 876.5010	1
NMX	Needle And Needle Set, Gastro-Urology, Reprocessed	Class 2	21 CFR 876.1075
NMY	Needle, Endoscopic, Reprocessed	Class 2	21 CFR 876.1500
NNE	Needle, Fistula, Reprocessed	Class 2	21 CFR 876.5540
NNG	Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed	Class 2	21 CFR 876.5820
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Class 1	21 CFR 876.5250
NNX	Device, Incontinence, Urosheath Type, Non-Sterile	Class 1	21 CFR 876.5250
NNY	Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile	Class 1	21 CFR 876.5250
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Steri	Class 1	21 CFR 876.5250
NOA	Device, Paste-On For Incontinence, Non-Sterile	Class 1	21 CFR 876.5250
NON	Forceps, Biopsy, Non-Electric, Reprocessed	Class 1	21 CFR 876.1075	3
NOO	Clamp, Dialysis Arm	Class 1	21 CFR 876.5540
NOY	Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	Class 2	21 CFR 876.5550	4
NQJ	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral	Class 2	21 CFR 876.5540	4
NQT	Dislodger, Stone, Flexible, Ureteral, Reprocessed	Class 2	21 CFR 876.4680
NQU	Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed	Class 2	21 CFR 876.4680
NQV	Catheter, Suction, Tracheobronchial, Reprocessed	Class 1	21 CFR 876.4680
NSI	System, Imaging, Esophageal, Wireless, Capsule	Class 2	21 CFR 876.1300	7
NTN	Led Light Source	Class 2	21 CFR 876.1500	9
NTZ	Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator	Class 2	21 CFR 876.5820	1
NUB	Colonic Irrigation System, General Well Being	Class 3	21 CFR 876.5220
NVE	Washer, Cleaner, Automated, Endoscope	Class 2	21 CFR 876.1500	12
NWB	Endoscope, Accessories, Narrow Band Spectrum	Class 2	21 CFR 876.1500	9
NWI	Electrosurgical Electrode Kit	Class 2	21 CFR 876.4300