Gastroenterology, Urology

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Code	Device name	Class	21 CFR	510(k) (3y)
BSS	Tube, Nasogastric	Class 2	21 CFR 876.5980	13
EXA	Selector, Size, Ostomy	Class 1	21 CFR 876.5900	1
EXB	Collector, Ostomy	Class 1	21 CFR 876.5900	102
EXD	Irrigator, Ostomy	Class 2	21 CFR 876.5895	12
EXE	Protector, Ostomy	Class 1	21 CFR 876.5900	3
EXF	Bag, Bile Collecting	Class 2	21 CFR 876.5010	9
EXG	Bag, Urine Collecting, Ureterostomy	Class 1	21 CFR 876.5900
EXH	Bag, Urinary, Ileostomy	Class 1	21 CFR 876.5900
EXI	Device, Paste-On For Incontinence, Sterile	Class 1	21 CFR 876.5250	7
EXJ	Device, Incontinence, Urosheath Type, Sterile	Class 1	21 CFR 876.5250	22
EXM	Truss, Umbilical	Class 1	21 CFR 876.5970
EXN	Support, Hernia	Class 1	21 CFR 876.5970	1
EXQ	Cystometer, Electrical Recording	Class 2	21 CFR 876.1620	8
EXR	Urinometer, Mechanical	Class 2	21 CFR 876.1800	9
EXS	Urinometer, Electrical	Class 2	21 CFR 876.1800
EXW	Pill, Radio	Class 2	21 CFR 876.1725	1
EXX	Probe, Rectal, Non-Powered	Class 1	21 CFR 876.4730
EXY	Uroflowmeter	Class 2	21 CFR 876.1800	16
EXZ	Equipment, Photographic, For Physiologic Function Monitor	Class 1	21 CFR 876.1500
EYA	Stylet, Ureteral	Class 1	21 CFR 876.5130
EYB	Catheter, Ureteral, Gastro-Urology	Class 2	21 CFR 876.5130	28
EYC	Catheter, Upper Urinary Tract	Class 2	21 CFR 876.5130	5
EYD	Stirrups	Class 1	21 CFR 876.4890
EYH	Table, Cysto, Non-Electrical	Class 1	21 CFR 876.4890
EYI	Adaptor, Ureteral Catheter	Class 1	21 CFR 876.5130
EYJ	Holder, Ureteral Catheter	Class 1	21 CFR 876.5130
EYK	Connector, Ureteral Catheter	Class 1	21 CFR 876.5130	1
EYN	Tray, Irrigation, Sterile	Class 2	21 CFR 876.5980	15
EYQ	Garment, Protective, For Incontinence	Class 1	21 CFR 876.5920	56
EYS	Ribdam	Class 1	21 CFR 876.4560
EYT	Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile	Class 1	21 CFR 876.5250	4
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Class 1	21 CFR 876.5250	14
EZB	Stylet For Catheter, Gastro-Urology	Class 1	21 CFR 876.5130	3
EZC	Catheter, Coude	Class 2	21 CFR 876.5130	7
EZD	Catheter, Straight	Class 2	21 CFR 876.5130	86
EZK	Catheter, Retention Type	Class 2	21 CFR 876.5980	3
EZL	Catheter, Retention Type, Balloon	Class 2	21 CFR 876.5130	129
EZM	Dilator, Esophageal (Metal Olive) Gastro-Urology	Class 2	21 CFR 876.5365
EZN	Dilator, Catheter, Ureteral	Class 2	21 CFR 876.5470	56
EZO	Urethrotome	Class 2	21 CFR 876.4770	5
EZP	Rod, Colostomy	Class 2	21 CFR 876.4270	2
EZQ	Pouch, Colostomy	Class 1	21 CFR 876.5900	6
EZR	Cement, Stomal Appliance, Ostomy	Class 1	21 CFR 876.5900	6
EZS	Appliance, Colostomy, Disposable	Class 1	21 CFR 876.5900	1
EZT	Pacemaker, Bladder	Class 3	21 CFR 876.5270
EZW	Stimulator, Electrical, Implantable, For Incontinence	Class 3	21 CFR 876.5270
EZY	Device, Incontinence, Mechanical/Hydraulic	Class 3	21 CFR 876.5280
FAD	Stent, Ureteral	Class 2	21 CFR 876.4620	122
FAE	Prosthesis, Penile	Class 2	21 CFR 876.3630	32
FAF	Prosthesis, Testicular	Class 3	21 CFR 876.3750
FAH	Dilator, Urethral, Mechanical	Class 2	21 CFR 876.5520	4
FAJ	Cystoscope And Accessories, Flexible/Rigid	Class 2	21 CFR 876.1500	92
FAK	Panendoscope (Gastroduodenoscope)	Class 2	21 CFR 876.1500	2
FAL	Panendoscope (Urethroscope)	Class 2	21 CFR 876.1500	1
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Class 2	21 CFR 876.1500	24
FAN	Sigmoidoscope, Rigid, Electrical	Class 2	21 CFR 876.1500	2
FAP	Cystometric Gas (Carbon-Dioxide) On Hydraulic Device	Class 2	21 CFR 876.1620	85
FAQ	Bag, Urine Collection, Leg, For External Use, Sterile	Class 1	21 CFR 876.5250	18
FAR	Unit, Electrosurgical	Class 2	21 CFR 876.4300
FAS	Electrode, Electrosurgical, Active, Urological	Class 2	21 CFR 876.4300	58
FAT	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology	Class 2	21 CFR 876.5365	8
FAX	Bougie, Urological	Class 1	21 CFR 876.5520	2
FBI	Rongeur, Cystoscopic	Class 2	21 CFR 876.1500
FBJ	Cord, Electric For Transurethral Surgical Instrument	Class 2	21 CFR 876.4300
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Class 2	21 CFR 876.1500	89
FBM	Cannula And Trocar, Suprapubic, Non-Disposable	Class 1	21 CFR 876.5090	9
FBN	Choledochoscope And Accessories, Flexible/Rigid	Class 2	21 CFR 876.1500	43
FBO	Cystourethroscope	Class 2	21 CFR 876.1500	19
FBP	Telescope, Rigid, Endoscopic	Class 2	21 CFR 876.1500	5
FBQ	Trocar, Gastro-Urology	Class 2	21 CFR 876.5090	9
FBR	Urethrometer	Class 1	21 CFR 876.5520
FBS	Sound, Metal, Interconnected	Class 1	21 CFR 876.4590	1
FBW	Filiform And Filiform Follower	Class 1	21 CFR 876.5520	1
FBX	Sound, Urethral, Metal Or Plastic	Class 1	21 CFR 876.5520	1
FCB	Bag, Hemostatic	Class 2	21 CFR 876.5980
FCC	Endoscopic Magnetic Retriever	Class 2	21 CFR 876.1500	3
FCD	Barium Enema Kit	Class 1	21 CFR 876.5210	2
FCE	Enema Kit	Class 1	21 CFR 876.5210	30
FCF	Instrument, Biopsy, Mechanical, Gastrointestinal	Class 2	21 CFR 876.1075	6
FCG	Biopsy Needle	Class 2	21 CFR 876.1075	133
FCH	Tray, Biopsy, Without Biopsy Instruments	Class 1	21 CFR 876.4730	2
FCI	Punch, Biopsy	Class 2	21 CFR 876.1075	5
FCK	Instrument, Biopsy, Suction	Class 2	21 CFR 876.1075	13
FCL	Forceps, Biopsy, Non-Electric	Class 1	21 CFR 876.1075	39
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit	Class 2	21 CFR 876.5130	60
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Class 2	21 CFR 876.5250	10
FCO	Box, Battery, Rechargeable	Class 1	21 CFR 876.1500	20
FCP	Box, Battery, Pocket	Class 1	21 CFR 876.1500	2
FCQ	Light Source, Incandescent, Diagnostic	Class 2	21 CFR 876.1500	1
FCR	Light Source, Photographic, Fiberoptic	Class 2	21 CFR 876.1500	3
FCS	Light, Catheter, Fiberoptic, Glass, Ureteral	Class 2	21 CFR 876.4020	10
FCW	Light Source, Fiberoptic, Routine	Class 2	21 CFR 876.1500	31
FCX	Insufflator, Automatic Carbon-Dioxide For Endoscope	Class 2	21 CFR 876.1500	25
FCY	Bulb, Inflation, For Endoscope	Class 1	21 CFR 876.1500	3
FCZ	Tube, Smoke Removal, Endoscopic	Class 1	21 CFR 876.1500
FDA	Enteroscope And Accessories	Class 2	21 CFR 876.1500	20
FDB	Plate, Patient	Class 2	21 CFR 876.4300
FDC	Resectoscope, Working Element	Class 2	21 CFR 876.1500	11
FDE	Laparoscopy Kit	Class 2	21 CFR 876.1500	4
FDF	Colonoscope And Accessories, Flexible/Rigid	Class 2	21 CFR 876.1500	114
FDG	Retractor, Fiberoptic	Class 1	21 CFR 876.4530	2
FDI	Snare, Flexible	Class 2	21 CFR 876.4300	63
FDJ	Snare, Rigid Self-Opening	Class 2	21 CFR 876.4300
FDL	Wristlet, Patient Return	Class 2	21 CFR 876.4300
FDP	Apparatus, Pneumoperitoneum, Automatic	Class 2	21 CFR 876.1500	1
FDR	Sphyncteroscope	Class 2	21 CFR 876.1500
FDS	Gastroscope And Accessories, Flexible/Rigid	Class 2	21 CFR 876.1500	78
FDT	Duodenoscope And Accessories, Flexible/Rigid	Class 2	21 CFR 876.1500	35
FDW	Esophagoscope, Rigid, Gastro-Urology	Class 2	21 CFR 876.1500
FDX	Endoscopic Cytology Brush	Class 2	21 CFR 876.1500	44
FDY	Device, Measuring, For Panendoscope	Class 1	21 CFR 876.1500
FDZ	Attachment, Eyepiece, For Insertion Of Prescription Lens	Class 1	21 CFR 876.1500	2
FEA	Attachment, Teaching, For Endoscope	Class 1	21 CFR 876.1500	2
FEB	Accessories, Cleaning, For Endoscope	Class 2	21 CFR 876.1500	57
FEC	Obturator, For Endoscope	Class 2	21 CFR 876.1500	3
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Class 2	21 CFR 876.1500	102
FEF	Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation	Class 2	21 CFR 876.5980	1
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Class 2	21 CFR 876.5980	13
FEH	Electrode, Flexible Suction Coagulator	Class 2	21 CFR 876.4300	3
FEI	Instrument, Special Lens, For Endoscope	Class 1	21 CFR 876.1500	2
FEJ	Attachment, Binocular, For Endoscope	Class 1	21 CFR 876.1500	1
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Class 1	21 CFR 876.1500	4
FEN	Device, Cystometric, Hydraulic	Class 2	21 CFR 876.1620	36
FEO	Lithotriptor, Ultrasonic	Class 2	21 CFR 876.4480	14
FEQ	Pump, Air, Non-Manual, For Endoscope	Class 2	21 CFR 876.1500	21
FER	Anoscope And Accessories	Class 2	21 CFR 876.1500	27
FES	Recorder, External, Pressure, Amplifier & Transducer	Class 2	21 CFR 876.1725	2
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Class 2	21 CFR 876.1500	100
FEW	Catheter, Malecot	Class 2	21 CFR 876.5090	6
FEX	Instrument, Catheter, Punch	Class 1	21 CFR 876.5090	2
FEZ	Catheter And Tube, Suprapubic	Class 2	21 CFR 876.5090	1
FFA	Tube, Drainage, Suprapubic	Class 2	21 CFR 876.5090	3
FFD	Evacuator, Bladder, Manually Operated	Class 1	21 CFR 876.4370	2
FFE	System, Water Jet Catheter, Renal	Class 2	21 CFR 876.4650	1
FFF	Cover, Biopsy Forceps	Class 1	21 CFR 876.1075	1
FFG	Device, Urine Flow Rate Measuring, Non-Electrical, Disposable	Class 2	21 CFR 876.1800	17
FFH	Collector, Urine, Pediatric, For Indwelling Catheter	Class 2	21 CFR 876.5250	3
FFI	System, Alarm, Electrosurgical	Class 2	21 CFR 876.4300	1
FFK	Lithotriptor, Electro-Hydraulic	Class 2	21 CFR 876.4480	61
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Class 2	21 CFR 876.4680	52
FFN	Clamp, Non-Electrical	Class 1	21 CFR 876.4730	5
FFO	Retractor, Self-Retaining	Class 1	21 CFR 876.4730	5
FFP	Dilator, Rectal	Class 1	21 CFR 876.5450	5
FFQ	Speculum, Rectal	Class 1	21 CFR 876.4730	1
FFR	Device, Locking, For Intestinal Clamp	Class 1	21 CFR 876.4730
FFS	Image, Illumination, Fiberoptic, For Endoscope	Class 2	21 CFR 876.1500	26
FFT	Electrode, Ph, Stomach	Class 1	21 CFR 876.1400	49
FFW	String And Tubes, Gastrointestinal, To Locate Internal Bleeding	Class 2	21 CFR 876.5980
FFX	System, Gastrointestinal Motility (Electrical)	Class 2	21 CFR 876.1725	69
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Class 1	21 CFR 876.1500	2
FFZ	Cord, Electric, For Endoscope	Class 2	21 CFR 876.1500	3
FGA	Kit, Nephroscope	Class 2	21 CFR 876.1500	10
FGB	Ureteroscope And Accessories, Flexible/Rigid	Class 2	21 CFR 876.1500	117
FGC	Urethroscope	Class 2	21 CFR 876.1500	3
FGD	Catheter, Retention, Barium Enema With Bag	Class 2	21 CFR 876.5980	6
FGE	Stents, Drains And Dilators For The Biliary Ducts	Class 2	21 CFR 876.5010	476
FGF	Catheter, Ureteral Disposable (X-Ray)	Class 2	21 CFR 876.5130	1
FGH	Catheter, Double Lumen Female Urethrographic	Class 2	21 CFR 876.5130	1
FGI	Catheter, Urethrographic, Male	Class 2	21 CFR 876.5130	3
FGK	Tripsor, Stone, Bladder	Class 2	21 CFR 876.4500	1
FGM	Probe And Director, Gastro-Urology	Class 1	21 CFR 876.4730	7
FGN	Retractor, Non-Self-Retaining	Class 1	21 CFR 876.4730
FGO	Dislodger, Stone, Flexible	Class 2	21 CFR 876.4680	19
FGS	Carrier, Sponge, Endoscopic	Class 2	21 CFR 876.1500	4
FGW	Clamp, Electrical	Class 2	21 CFR 876.4300
FGX	Snare, Non-Electrical	Class 1	21 CFR 876.4730
FHA	Clamp, Penile	Class 1	21 CFR 876.5160	11
FHB	Hook, Gastro-Urology	Class 1	21 CFR 876.4730
FHC	Adaptor To The Cord, For Transurethral Surgical Instrument	Class 2	21 CFR 876.4300
FHF	System, Evacuator, Fluid	Class 2	21 CFR 876.4370	3
FHH	Crusher, Spur, Colostomy	Class 1	21 CFR 876.4730
FHI	Ring, Laparotomy	Class 1	21 CFR 876.4730
FHK	Spreader, Bladder Neck	Class 1	21 CFR 876.4730
FHL	Scoop	Class 1	21 CFR 876.4730
FHN	Ligator, Hemorrhoidal	Class 2	21 CFR 876.4400	22
FHO	Pneumoperitoneum Needle	Class 2	21 CFR 876.1500	15
FHP	Needle, Pneumoperitoneum, Simple	Class 2	21 CFR 876.1500	2
FHQ	Holder, Needle, Gastroenterologic	Class 1	21 CFR 876.4730	7
FHS	Dialyzer, Single Coil	Class 2	21 CFR 876.5820	12
FHT	Set, Gavage, Infant, Sterile	Class 2	21 CFR 876.5980	1
FHW	Device, Impotence, Mechanical/Hydraulic	Class 3	21 CFR 876.3350
FHX	Jelly, Lubricating, For Transurethral Surgical Instrument	Class 2	21 CFR 876.1500	6
FHY	Jelly, Contact, For Transurethral Surgical Instrument	Class 2	21 CFR 876.4300
FHZ	Desiccator, Transurethral	Class 2	21 CFR 876.4300
FIA	Chair, Dialysis, Unpowered, Without Scales	Class 1	21 CFR 876.5820
FIB	Protector, Transducer, Dialysis	Class 2	21 CFR 876.5820	35
FID	Tubing, Dialysate	Class 2	21 CFR 876.5820	3
FIE	Needle, Fistula	Class 2	21 CFR 876.5540	80
FIF	Set, Dialysis, Single Needle With Uni-Directional Pump	Class 2	21 CFR 876.5820	6
FIG	Clamp, Tubing, Blood, Automatic	Class 2	21 CFR 876.5820	4
FIH	Pump, Infusion Or Syringe, Extra-Luminal	Class 2	21 CFR 876.5820	5
FII	System, Dialysate Delivery, Sealed	Class 2	21 CFR 876.5860	5
FIJ	System, Dialysate Delivery, Recirculating, Single Pass	Class 2	21 CFR 876.5820	1
FIK	System, Dialysate Delivery, Recirculating	Class 2	21 CFR 876.5820
FIL	System, Dialysate Delivery, Single Pass	Class 2	21 CFR 876.5820	8
FIN	Tank, Holding, Dialysis	Class 2	21 CFR 876.5820	18
FIP	Subsystem, Water Purification	Class 2	21 CFR 876.5665	117
FIQ	Cannula, A-V Shunt	Class 2	21 CFR 876.5540	23
FIR	Pump, Blood, Extra-Luminal	Class 2	21 CFR 876.5820	7
FIS	Flowmeter, Dialysate	Class 2	21 CFR 876.5820