General, Plastic Surgery

Page 3 of 3

Code	Device name	Class	21 CFR	510(k) (3y)
OTK	Wound Drain Catheter System	Class 2	21 CFR 878.4780	7
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	Class 2	21 CFR 878.3300	12
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontin	Class 2	21 CFR 878.3300	65
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uter	Class 2	21 CFR 878.3300	23
OUB	Instrument For Treatment Of Hyperhidrosis	Class 2	21 CFR 878.4400	3
OUH	Skin Resurfacing Rf Applicator	Class 2	21 CFR 878.4400	5
OUK	Surgical Mask With Antimicrobial/Antiviral Agent	Class 2	21 CFR 878.4040	4
OUP	Powered Surgical Instrument For Improvement In The Appearance Of Cellu	Class 2	21 CFR 878.4790	9
OVN	Suture Kit	Class 2	21 CFR 878.4830
OVR	Kit, First Aid, Talking	Class 1	21 CFR 878.4014	1
OWR	Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery	Class 2	21 CFR 878.3300	1
OWS	Mesh, Surgical, Collagen, Plastics, Facial Implants	Class 2	21 CFR 878.3300
OWT	Mesh, Surgical, Absorbable, Abdominal Hernia	Class 2	21 CFR 878.3300	11
OWU	Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia	Class 2	21 CFR 878.3300
OWV	Mesh, Surgical, Collagen, Diaphragmatic Hernia	Class 2	21 CFR 878.3300	1
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	Class 2	21 CFR 878.3300	10
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	Class 2	21 CFR 878.3300	5
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	Class 2	21 CFR 878.3300	14
OWZ	Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction	Class 2	21 CFR 878.3300
OXA	Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction	Class 2	21 CFR 878.3300
OXB	Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	Class 2	21 CFR 878.3300
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	Class 2	21 CFR 878.3300	9
OXD	Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement	Class 2	21 CFR 878.3300	3
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	Class 2	21 CFR 878.3300	4
OXF	Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery	Class 2	21 CFR 878.3300	8
OXG	Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery	Class 2	21 CFR 878.3300
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	Class 2	21 CFR 878.3300	5
OXI	Mesh, Surgical, Absorbable, Large Abdominal Wall Defects	Class 2	21 CFR 878.3300
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects	Class 2	21 CFR 878.3300	2
OXK	Mesh, Surgical, Collagen, Large Abdominal Wall Defects	Class 2	21 CFR 878.3300	2
OXL	Mesh, Surgical, Absorbable, Organ Support	Class 2	21 CFR 878.3300
OXM	Mesh, Surgical, Absorbable, Fistula	Class 2	21 CFR 878.3300
OXN	Mesh, Surgical, Collagen, Fistula	Class 2	21 CFR 878.3300	1
OXT	Percutaneous Surgical Set With Attachments	Class 2	21 CFR 878.4805	1
OXZ	Pediatric/Child Facemask	Class 2	21 CFR 878.4040	9
OYD	Optical Diagnostic Device For Melanoma Detection	Class 2	21 CFR 878.1820
OYW	Laser, Cellulite Appearance	Class 2	21 CFR 878.4810	2
PAG	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Inco	Class 2	21 CFR 878.3300	9
PAH	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontin	Class 2	21 CFR 878.3300	20
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And	Class 2	21 CFR 878.3300	2
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reducti	Class 2	21 CFR 878.4420	12
PBD	Composite Cultured Skin	Class F	21 CFR 878.4024
PBX	Massager, Vacuum, Radio Frequency Induced Heat	Class 2	21 CFR 878.4400	79
PBY	Temporary Tissue Marker	Class 2	21 CFR 878.4300	7
PDG	Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.	Class 2	21 CFR 878.4400	1
PDW	Internal Tissue Marker	Class 2	21 CFR 878.4670	3
PDZ	Lasers For Temporary Increase Of Clear Nail In Patients With Onychomyc	Class 2	21 CFR 878.4810	19
PEM	Dental Barriers And Sleeves	Class 2	21 CFR 878.4370	15
PFP	Silicone Hydrogel For Scar Management	Class 1	21 CFR 878.4025	1
PGZ	Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal U	Class 2	21 CFR 878.4452	7
PIJ	Collagen Surgical Mesh Containing Drugs	Class 2	21 CFR 878.3300	3
PIR	Mercy Tape 2d And 3d Models	Class 1	21 CFR 878.4800	2
PJK	Tissue Adhesive For Internal Use	Class 3	21 CFR 878.4010
PKD	Laceration Tray	Class 1	21 CFR 878.4014
PKE	Laparoscopic Cholecystectomy Kit	Class 1	21 CFR 878.4800
PKO	Transparent Patch For Use In Treatment Of Tattoos	Class 2	21 CFR 878.4810	2
PKT	Laser For Disruption Of Adipocyte Cells For Aesthetic Use	Class 2	21 CFR 878.5400	19
PLJ	Tissue Adhesive Internal Use	Class 3	21 CFR 878.4010
PLY	Antimicrobial Drapes	Class 2	21 CFR 878.4370
PMC	Scalp Cooling System	Class 2	21 CFR 878.4360	7
PMX	Absorbable Collagen Hemostatic Agent With Thrombin	Class 3	21 CFR 878.4490
PNL	Magnetic Surgical System	Class 2	21 CFR 878.4815	8
POD	Temporary, Internal Use Hemostatic	Class 2	21 CFR 878.4454	6
PPP	Disposable Joint Aspiration/Injection Kit	Class 1	21 CFR 878.4800
PQI	Wound Retraction And Protection System	Class 2	21 CFR 878.4371	2
PQM	Surgical Smoke Precipitator	Class 2	21 CFR 878.5050	7
PQN	Carbon Dioxide Gas Controlled Tissue Expander	Class 2	21 CFR 878.3510	3
PSN	Light Based Imaging	Class 2	21 CFR 878.4580	10
PTX	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile,	Class 2	21 CFR 878.4495
PUI	Drape, Surgical, Exempt	Class 2	21 CFR 878.4370
PXN	Basic Set-Up Tray	Class 1	21 CFR 878.4800
PXO	Bone Marrow Biopsy Tray	Class 1	21 CFR 878.4800
PXP	Breast Biopsy / Localization Tray	Class 1	21 CFR 878.4800
PXQ	Burn Dressing Tray	Class 1	21 CFR 878.4022
PXR	Cement And Bone Removal Kit	Class 1	21 CFR 878.4820
PXS	Cholecystectomy Kit	Class 1	21 CFR 878.4800
PXU	Fluid Drainage Tray	Class 1	21 CFR 878.4200
PXV	General Purpose Instrument Tray	Class 1	21 CFR 878.4800
PXW	Herniorraphy Kit	Class 1	21 CFR 878.4800
PXX	Incision Tray	Class 1	21 CFR 878.4800
PXY	Irrigation Kit (Wounds)	Class 1	21 CFR 878.4014
PXZ	Laparascopic Sphincterotomy Kit	Class 1	21 CFR 878.4800
PYA	Liver Biopsy Kit	Class 1	21 CFR 878.4800
PYB	Minor Surgical Procedures Tray	Class 1	21 CFR 878.4800
PYC	Paracentesis Tray	Class 1	21 CFR 878.4200
PYD	Pelviscopy Kit	Class 1	21 CFR 878.4800
PYE	Staple Removal Kit	Class 1	21 CFR 878.4760	1
PYF	Sterile Puncture Tray	Class 1	21 CFR 878.4800
PYG	Suction Catheter Kit	Class 1	21 CFR 878.4200
PYH	Surgical Retractor Kit	Class 1	21 CFR 878.4800
PYI	Thoracic Catheter Insertion Tray	Class 1	21 CFR 878.4200
PYJ	Ulcer Wound Tray	Class 1	21 CFR 878.4014
PYK	Venous Ulcer Kit	Class 1	21 CFR 878.4014
PYL	Wound Drainage Kit	Class 1	21 CFR 878.4014
PYU	Sponge, Eyelid Cleaning, Powered	Class 1	21 CFR 878.4820
PZL	Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	Class 2	21 CFR 878.4685	8
PZP	Fluid Jet Removal System	Class 2	21 CFR 876.4350	9
PZQ	General Laparoscopic Power Morcellation Containment System	Class 2	21 CFR 878.4825	1
PZX	Left Atrial Appendage Clip, Implantable	Class 2	21 CFR 878.4300	10
QAI	Powered Microneedle Device	Class 2	21 CFR 878.4430	26
QAU	Hemostatic Device For Endoscopic Gastrointestinal Use	Class 2	21 CFR 878.4456	12
QBW	Surgical Apparel With Material Claims	Class 2	21 CFR 878.4040	1
QCR	Wound Autofluorescence Imaging Device	Class 1	21 CFR 878.4165	1
QCY	Laser Absorbing Particles	Class 2	21 CFR 878.4810	2
QDF	Parathyroid Autofluorescence Detection Device	Class 2	21 CFR 878.4550	1
QDG	Parathyroid Autofluorescence Imaging Device	Class 2	21 CFR 878.4550	6
QFC	Negative Pressure Wound Therapy Device For Reduction Of Wound Complica	Class 2	21 CFR 878.4783	3
QGI	Air-Handling Apparatus Accessory	Class 1	21 CFR 878.5080
QGM	Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation	Class 2	21 CFR 878.4405	3
QGX	General Use Pneumatic Tourniquet	Class 1	21 CFR 878.5910
QHF	Energy Based Device For Treatment Of Tattoos	Class 2	21 CFR 878.4810
QJF	Autofluorescence Imaging Adjunct Tool For Wounds	Class 2	21 CFR 878.4550	7
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	Class 2	21 CFR 878.5040
QML	Anal Fistula Closure Device	Class 2	21 CFR 878.4835	1
QMX	Label Or Tag, Non-Sterile	Class 1	21 CFR 878.4800
QNM	Mountable Electromechanical Surgical System For Transluminal Approache	Class 2	21 CFR 878.4961	8
QPB	System, Suction, Lipoplasty For Removal	Class 2	21 CFR 878.5040	59
QPC	Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High	Class 2	21 CFR 878.4040	11
QPE	Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical	Class 2	21 CFR 878.4880	1
QPX	Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical	Class 2	21 CFR 878.4683	1
QPZ	Contact Cooling For Skin Lesion Pain Relief	Class 2	21 CFR 878.4340	2
QQO	Cranial Measurement Software	Class 1	21 CFR 878.4800	1
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevent	Class 2	21 CFR 878.4850	17
QRL	Multiple Use Blood Lancet For Single Patient Use Only	Class 2	21 CFR 878.4850	27
QRM	Multiple Use Blood Lancet For Multiple Patient Use	Class 3	21 CFR 878.4850
QSO	Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With	Class 2	21 CFR 878.4040
QUB	Suction Lipoplasty System For Removal And Transfer	Class 2	21 CFR 878.5040
QUQ	Knife, Intraocular Pressure Lowering	Class 2	21 CFR 878.4400	1
QUW	Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament	Class 2	21 CFR 878.3300	5
QVJ	Low Power Electrosurgical Devices For Skin Lesion Destruction	Class 2	21 CFR 878.4400	4
QVS	Breast Implant Suction Retrieval Device	Class 2	21 CFR 878.4675	2
QVX	Skin Patch For Treatment Of Hyperhidrosis	Class 2	21 CFR 878.4425	1
QWJ	Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of L	Class 2	21 CFR 878.3300	1
QXW	Cryoablation Device For Local Treatment Of Low-Risk Breast Cancer	Class 2	21 CFR 878.4355	1
QYK	Semi-Automated Autologous Skin Graft Harvesting And Application Device	Class 2	21 CFR 878.4795	1
QZN	Multi-Photon Imaging	Class 2	21 CFR 878.4580	1
QZS	Software-Aided Adjunctive Diagnostic Device For Use By Physicians On L	Class 2	21 CFR 878.1830	1
RAB	Sunlamp Products (Pre-Standard)	Class 2	21 CFR 878.4635
REF	Suntan Bed	Class 2	21 CFR 878.4635
REG	Suntan Lamp	Class 2	21 CFR 878.4635
REH	Tabletop Sunlamp System	Class 2	21 CFR 878.4635
SAB	Table Mounted Miniaturized Electromechanical Surgical System	Class 2	21 CFR 878.4962	2
SAH	Magnetic Compression Anastomosis System	Class 2	21 CFR 878.4816	8
SAM	Battery-Powered Instruments Charged Through Sterile Barriers	Class 1	21 CFR 878.4820	1
SAQ	Electromechanical System For Open Microsurgery	Class 2	21 CFR 878.4963	5
SCV	Modular Electromechanical Surgical System	Class 2	21 CFR 878.4964	4
SDD	Electromechanical Surgical System Wherein The Surgeon Annd The User In	Class 2	21 CFR 878.4965	5
SFG	Camera, Surgical, Measurement	Class 1	21 CFR 878.4160	1
SFQ	Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Elec	Class 2	21 CFR 878.4400
SGV	Agent, Absorbable Hemostatic, Collagen With Polymeric Additives	Class 3	21 CFR 878.4490
SGZ	Ultraviolet Lamp Products	Class 2	21 CFR 878.4635	1
SHA	Solid Wound Dressing With Permanently Bound Antimicrobial Agent	Class 2	21 CFR 878.4013	1
SHY	Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Prov	Class 2	21 CFR 878.1840	1
SIR	Integrated Operating Table-Electromechanical Surgical System	Class 2	21 CFR 878.4966	1