General, Plastic Surgery

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Code	Device name	Class	21 CFR	510(k) (3y)
HCF	Instrument, Ligature Passing And Knot Tying	Class 1	21 CFR 878.4800	5
HJE	Lamp, Fluorescein, Ac-Powered	Class 2	21 CFR 878.4580	3
HMP	Pad, Eye	Class 1	21 CFR 878.4440	17
HMT	Drape, Patient, Ophthalmic	Class 2	21 CFR 878.4370	7
HMW	Drape, Microscope, Ophthalmic	Class 2	21 CFR 878.4370	4
HRB	Microscope, Operating, Non-Electric, Ophthalmic	Class 1	21 CFR 878.4700
HRM	Microscope, Operating & Accessories, Ac-Powered, Ophthalmic	Class 1	21 CFR 878.4700	14
HRQ	Hemostat	Class 1	21 CFR 878.4800	15
HSO	Saw	Class 1	21 CFR 878.4800
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attach	Class 1	21 CFR 878.4820	56
HTC	Pliers, Surgical	Class 1	21 CFR 878.4800	10
HTD	Forceps	Class 1	21 CFR 878.4800	73
HTE	Elevator	Class 1	21 CFR 878.4800
HTF	Curette	Class 1	21 CFR 878.4800	3
HTR	Rasp	Class 1	21 CFR 878.4800	9
HTZ	Instrument, Cutting, Orthopedic	Class 1	21 CFR 878.4800	21
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attac	Class 1	21 CFR 878.4820	76
HWM	Osteotome	Class 1	21 CFR 878.4800	3
HXD	Clamp	Class 1	21 CFR 878.4800	14
HXL	Mallet	Class 1	21 CFR 878.4800	3
HXR	Spatula, Orthopedic	Class 1	21 CFR 878.4800	4
HXT	Tape, Orthopedic	Class 1	21 CFR 878.4800
HYA	Forceps, Wire Holding	Class 1	21 CFR 878.4800
JCQ	Prosthesis, Esophagus	Class 2	21 CFR 878.3610	1
JCT	Prosthesis, Tracheal, Expandable	Class 2	21 CFR 878.3720	45
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	Class 2	21 CFR 878.4780	77
JCY	Catheter, Infusion	Class 1	21 CFR 878.4200	14
JDJ	Mesh, Surgical, Acetabular, Hip, Prosthesis	Class 2	21 CFR 878.3300	7
JDK	Prosthesis, Hip, Cement Restrictor	Class 2	21 CFR 878.3300	54
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	Class 1	21 CFR 878.4960	10
JEB	Table, Surgical With Orthopedic Accessories, Manual	Class 1	21 CFR 878.4950	13
JOS	Electrode, Electrosurgical	Class 2	21 CFR 878.4400	36
JOT	Electrode, Gel, Electrosurgical	Class 2	21 CFR 878.4400	9
JYC	Cannula, Ear	Class 1	21 CFR 878.4800	2
JYD	Chisel, Mastoid	Class 1	21 CFR 878.4800	1
JYK	Holder, Ear Speculum	Class 1	21 CFR 878.1800	1
KAG	Holder, Speculum, Ent	Class 1	21 CFR 878.1800	2
KAM	Cannula, Sinus	Class 1	21 CFR 878.4800	19
KAN	Chisel, Nasal	Class 1	21 CFR 878.4800
KCE	Cannulae, Bronchial	Class 1	21 CFR 878.4800
KCW	Epilator, High Frequency, Needle-Type	Class 1	21 CFR 878.5350	43
KCX	Epilator, High Frequency, Tweezer-Type	Class 1	21 CFR 878.5360	25
KCY	Tourniquet, Pneumatic	Class 1	21 CFR 878.5910	34
KCZ	Prosthesis, Breast, External, Used With Adhesive	Class 1	21 CFR 878.3800	13
KDA	Prosthesis, Ptfe/Carbon-Fiber	Class 2	21 CFR 878.3500	1
KDC	Instrument, Surgical, Disposable	Class 1	21 CFR 878.4800	67
KDD	Kit, Surgical Instrument, Disposable	Class 1	21 CFR 878.4800	62
KDG	Chisel (Osteotome)	Class 1	21 CFR 878.4820	11
KFK	Saw, Pneumatically Powered	Class 1	21 CFR 878.4820	4
KGL	Cabinet, Phototherapy (Puva)	Class 2	21 CFR 878.4630	8
KGO	Surgeon'S Gloves	Class 1	21 CFR 878.4460	560
KGQ	Cream, Gloving, Surgeon'S	Class 1	21 CFR 878.4470	1
KGS	Retention Device, Suture	Class 1	21 CFR 878.4930	20
KGT	Drape, Adhesive, Aerosol	Class 1	21 CFR 878.4380	1
KGW	Ring (Wound Protector), Drape Retention, Internal	Class 2	21 CFR 878.4370	9
KGY	Bag, Intestine	Class 1	21 CFR 878.4100	6
KGZ	Accessories, Catheter	Class 1	21 CFR 878.4200	29
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attac	Class 1	21 CFR 878.4820	29
KIK	Hook, Bone	Class 1	21 CFR 878.4800	1
KKX	Drape, Surgical, Antimicrobial	Class 2	21 CFR 878.4370	450
KKY	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial R	Class 2	21 CFR 878.3500	25
KOX	Solvent, Adhesive Tape	Class 1	21 CFR 878.4730	12
KOY	Degreaser, Skin, Surgical	Class 1	21 CFR 878.4730
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	Class 1	21 CFR 878.4018	22
KPJ	Chamber, Oxygen, Topical, Extremity	Class 2	21 CFR 878.5650	23
KPK	Marker, Ostia, Aorto-Saphenous Vein	Class 2	21 CFR 878.4650	6
KQM	Camera, Surgical And Accessories	Class 1	21 CFR 878.4160	18
LEJ	Booth, Sun Tan	Class 2	21 CFR 878.4635	81
LGX	Table, Examination, Medical, Powered	Class 1	21 CFR 878.4960	14
LMF	Agent, Absorbable Hemostatic, Collagen Based	Class 3	21 CFR 878.4490
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	Class 3	21 CFR 878.4490
LNK	Laser For Gastro-Urology Use	Class 2	21 CFR 878.4810	60
LRO	General Surgery Tray	Class 2	21 CFR 878.4370	110
LRP	Tray, Surgical	Class 1	21 CFR 878.4800	22
LRW	Scissors, General, Surgical	Class 1	21 CFR 878.4800	18
LRY	Punch, Surgical	Class 1	21 CFR 878.4800	7
LRZ	Screwdriver, Surgical	Class 1	21 CFR 878.4800	3
LSA	Vise, Bench, Surgical	Class 1	21 CFR 878.4800	1
LWG	Surgical Table Cushion	Class 1	21 CFR 878.4950	4
LWK	Razor, Surgical	Class 1	21 CFR 878.4800	4
LXI	Guide, Drill, Ligament	Class 1	21 CFR 878.4820	8
LXK	Scrapper, Skin Specimen	Class 1	21 CFR 878.4800	1
LXZ	Guard, Instrument	Class 1	21 CFR 878.4800	2
LYU	Accessory, Surgical Apparel	Class 1	21 CFR 878.4040	56
LYV	Label Or Tag, Sterile	Class 1	21 CFR 878.4800	2
LZK	Implant, Malar	Class 2	21 CFR 878.3550	40
LZM	Guard, Skin Graft	Class 1	21 CFR 878.4014	2
LZN	Cement Obturator	Class 2	21 CFR 878.3300	37
MAC	Decontamination Kit	Class 1	21 CFR 878.4014	2
MAW	Marker, Suture Identification	Class 1	21 CFR 878.4800	1
MCA	Tape, Surgical, Internal	Class 2	21 CFR 878.3300	1
MCH	Clip, Hemostatic	Class 2	21 CFR 878.4300	3
MCZ	Suture Removal Kit	Class 1	21 CFR 878.4800	15
MDA	Elastomer, Silicone, For Scar Management	Class 1	21 CFR 878.4025	81
MDM	Instrument, Manual, Surgical, General Use	Class 1	21 CFR 878.4800	44
MGO	Closure, Wound, Adhesive	Class 1	21 CFR 878.4018	1
MIJ	Needle, Tumor Localization	Class 1	21 CFR 878.4800
MJG	Device, Percutaneous, Biopsy	Class 1	21 CFR 878.4800	7
MKY	System, Skin Closure	Class 1	21 CFR 878.4320	6
MMP	Cover, Barrier, Protective	Class 2	21 CFR 878.4370	15
MNF	Implant, Temporal	Class 2	21 CFR 878.3550	2
MOQ	Battery, Replacement, Rechargeable	Class 1	21 CFR 878.4820	3
MPN	Tissue Adhesive For The Topical Approximation Of Skin	Class 2	21 CFR 878.4010	36
MQR	Stent, Colonic, Metallic, Expandable	Class 2	21 CFR 878.3610	16
MSA	Dressing, Wound And Burn, Occlusive, Heated	Class 1	21 CFR 878.4020	2
MSH	Respirator, Surgical	Class 2	21 CFR 878.4040	35
MUK	Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Fe	Class 2	21 CFR 878.4400	3
MUL	Generator, Electrosurgical, Coagulation, Cancer	Class 2	21 CFR 878.4400
MUM	Stent, Metallic, Expandable, Duodenal	Class 2	21 CFR 878.3610	6
MUU	System, Suction, Lipoplasty	Class 2	21 CFR 878.5040	40
MVR	Device, Anastomotic, Microvascular	Class 2	21 CFR 878.4300	9
MWY	System, Microwave, Hair Removal	Class 2	21 CFR 878.4400	2
MXG	Lamp, Uvc, (For Treating Skin And Wounds)	Class 2	21 CFR 878.4630	1
MXW	Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)	Class 2	21 CFR 878.5010	2
NAB	Gauze / Sponge,Nonresorbable For External Use	Class 1	21 CFR 878.4014	88
NAC	Dressing, Wound, Hydrophilic	Class 1	21 CFR 878.4018	4
NAD	Dressing, Wound, Occlusive	Class 1	21 CFR 878.4020	107
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	Class 1	21 CFR 878.4022	29
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	Class 2	21 CFR 878.5035	17
NCA	Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)	Class 2	21 CFR 878.4300	3
NEH	Anchor, Fascial	Class 2	21 CFR 878.4300	1
NEJ	System, Cryosurgical, Liquid Nitrogen, For Gastroenterology	Class 2	21 CFR 878.4350
NEU	Marker, Radiographic, Implantable	Class 2	21 CFR 878.4300	110
NEW	Suture, Surgical, Absorbable, Polydioxanone	Class 2	21 CFR 878.4840	66
NEY	System, Ablation, Microwave And Accessories	Class 2	21 CFR 878.4400	68
NJC	Clip, Vas Deferens	Class 2	21 CFR 878.4300	2
NJU	Suture, Nonabsorbable, Nitinol	Class 2	21 CFR 878.4495	2
NJZ	Extractor, Vein	Class 1	21 CFR 878.4800
NLK	Needle, Biopsy, Cardiovascular, Reprocessed	Class 1	21 CFR 878.4800
NLL	Staple, Implantable, Reprocessed	Class 2	21 CFR 878.4750	3
NMJ	Clip, Implantable, Reprocessed	Class 2	21 CFR 878.4300	1
NMT	Needle, Catheter, Reprocessed	Class 1	21 CFR 878.4200
NMU	Needle, Gastro-Urology, Reprocessed	Class 1	21 CFR 878.4800
NNA	Biopsy Device, Percutaneous, Reprocessed	Class 1	21 CFR 878.4800
NNC	Needle, Aspiration And Needle, Reprocessed	Class 1	21 CFR 878.4800
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	Class 1	21 CFR 878.3910
NOD	Board, Arm (With Cover), Non-Sterile	Class 1	21 CFR 878.3910
NOJ	Prosthesis, Breast, External, No Adhesive	Class 1	21 CFR 878.3800
NOK	Material, External Aesthetic Restoration, No Adhesive	Class 1	21 CFR 878.3800
NRB	Wound Cleaner, Ultrasound	Class 2	21 CFR 878.4410	9
NRJ	Ultrasound, Skin Permeation	Class 2	21 CFR 878.4410	1
NTB	System, Ablation, Ultrasound And Accessories	Class 2	21 CFR 878.4400	6
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & End	Class 2	21 CFR 878.4400	37
NUV	Massager, Vacuum, Light Induced Heating	Class 2	21 CFR 878.4810	20
NVH	Suture, Knot, Mechanical	Class 2	21 CFR 878.4300	1
NVJ	Applicator, Transurethral, Radio Frequency, For Stress Urinary Inconti	Class 2	21 CFR 878.4400	1
NVK	Laser, Dental, Soft Tissue	Class 2	21 CFR 878.4810	17
NWA	Prosthesis, Tracheal, Preformed/Molded	Class 2	21 CFR 878.3720	7
NWF	Drill, Battery Powered, Subungual Hematoma	Class 1	21 CFR 878.4820	1
NWJ	Suture, Recombinant Technology	Class 2	21 CFR 878.4494	9
NXF	Gas, Laser Generating	Class 1	21 CFR 878.4810
NYS	Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)	Class 2	21 CFR 878.4015	1
NYT	Prosthesis, Tracheal, Expandable, Polymeric	Class 2	21 CFR 878.3720	3
NZP	Sealant, Microbial	Class 2	21 CFR 878.4370	4
OAB	Low Energy Direct Current Thermal Ablation System	Class 2	21 CFR 878.4400	15
OAJ	Catheter, Drainage, Intraoral/Extraoral	Class 1	21 CFR 878.4200	1
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue,	Class 2	21 CFR 878.4400	54
ODR	Electrosurgical Patient Return Electrode	Class 2	21 CFR 878.4400	3
ODU	Facial Implant	Class 2	21 CFR 878.3500	1
OEA	Non-Surgical Gown	Class 1	21 CFR 878.4040
OEI	Drainage Catheter With Antibiotic	Class 2	21 CFR 878.4780	1
OEL	Laser, Benign Prostatic Hyperplasia	Class 2	21 CFR 878.4810
OHO	First Aid Kit Without Drug	Class 1	21 CFR 878.4014
OHS	Light Based Over The Counter Wrinkle Reduction	Class 2	21 CFR 878.4810	162
OHT	Light Based Over-The-Counter Hair Removal	Class 2	21 CFR 878.4810	163
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	Class 2	21 CFR 878.4590	30
OJH	Orthopedic Tray	Class 1	21 CFR 878.4800
OJJ	Burn Kit Without Drug	Class 1	21 CFR 878.4022
OJR	Vacuum Powered Body Fluid Collection Kit	Class 2	21 CFR 878.4780
OJS	Tourniquet Kit	Class 1	21 CFR 878.5900
OJT	Aspiration Tray	Class 1	21 CFR 878.4800
OJU	Skin Prep Tray	Class 1	21 CFR 878.4800	1
OJV	Single Use Instrument Tray	Class 1	21 CFR 878.4800
OJW	Shave Prep Kit	Class 2	21 CFR 878.4370
OKF	Body Fluid Disposal Kit	Class 2	21 CFR 878.4040
OKG	Body Fluid Clean Up Kit	Class 2	21 CFR 878.4040
OKH	Body Fluids Barrier Kit	Class 2	21 CFR 878.4040
OKI	Emergency Response Safety Kit	Class 2	21 CFR 878.4040
OKJ	Light Based Treatment For Cold Sores Herpes Simplex Virus-1	Class 2	21 CFR 878.4860	4
OKO	Negative Pressure Wound Therapy Non-Powered Suction Apparatus	Class 2	21 CFR 878.4683	17
OLC	Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White	Class 2	21 CFR 878.3300	3
OLI	Fat Reducing Low Level Laser	Class 2	21 CFR 878.5400	33
OLL	Septal Stapler/Absorbable Staples	Class 2	21 CFR 878.4750	1
OLP	Over-The-Counter Powered Light Based Laser For Acne	Class 2	21 CFR 878.4810	51
OMD	Cutaneous Tissue Adhesive With Mesh	Class 2	21 CFR 878.4011	9
OMP	Negative Pressure Wound Therapy Powered Suction Pump	Class 2	21 CFR 878.4780	214
OMT	Absorbable Lung Biopsy Plug	Class 2	21 CFR 878.4755	2
ONE	Powered Light Based Non-Laser Surgical Instrument	Class 2	21 CFR 878.4810	7
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	Class 2	21 CFR 878.4810	74
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	Class 2	21 CFR 878.4810	35
ONO	Neurosurgical Laser With Mr Thermography	Class 2	21 CFR 878.4810	7
ONQ	Electrosurgical Coagulation For Aesthetic	Class 2	21 CFR 878.4400	4
ONT	N95 Respirator With Antimicrobial/Antiviral Agent	Class 2	21 CFR 878.4040	6
ONV	Electrical Impedance Spectrometer	Class 2	21 CFR 878.1820
OOD	Surgical Film	Class 2	21 CFR 878.3300	13
OOK	Dermal Cooling Pack/Vacuum/Massager	Class 2	21 CFR 878.4340	14
OQL	Mesh, Surgical, Deployment Balloon	Class 2	21 CFR 878.3300	1
ORC	Air Filter Portable Apparatus	Class 2	21 CFR 878.5070	6
ORK	Laser Assisted Lipolysis	Class 2	21 CFR 878.4810	1
ORQ	Mesh, Surgical, Deployer	Class 2	21 CFR 878.3300	6