FDA Review Panel · SU

FDA 510(k) General & Plastic Surgery Devices

FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview

FDA 510(k) general and plastic surgery devices represent the largest 510(k) category with 18,104 submissions since 1976. The FDA review panel code is SU.

This panel covers a broad range of surgical equipment:

  • Electrosurgical units (ESU) - monopolar and bipolar cutting and coagulation
  • Surgical lasers - CO2, Nd:YAG, diode and excimer surgical lasers
  • Laparoscopic instruments - trocars, graspers, staplers, clip appliers
  • Wound care and closure - negative pressure therapy, staples, tissue adhesives
  • Aesthetic devices - body contouring, skin resurfacing, fat reduction systems

18256
Total
18211
Cleared
137d
Avg (2y)
1976
Since
7710 General & Plastic Surgery devices
4876–4900 of 7710
Cleared Dec 09, 1997
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS
K973470 · Lumenis, Inc.
GEX · Powered Laser Surgical Instrument · 88d
Cleared Dec 09, 1997
TORNIER CEMENT RESTRICTOR
K973453 · Tornier
JDI · Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented · 89d
Cleared Dec 05, 1997
ETHICON NON-STICK BIPOLAR FORCEPS
K973384 · Ethicon, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 88d
Cleared Dec 04, 1997
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
K973703 · Allegiance Healthcare Corp.
GBX · Catheter, Irrigation · 69d
Cleared Dec 04, 1997
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
K973509 · Kendall Healthcare Products Co. Div.Of Tyco Health
KMF · Bandage, Liquid · 79d
Cleared Dec 04, 1997
SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)
K973354 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Dec 04, 1997
CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
K972767 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 133d
Cleared Nov 26, 1997
BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451
K973295 · Richard Wolf Medical Instruments Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 85d
Cleared Nov 25, 1997
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc.
KMF · Bandage, Liquid · 90d
Cleared Nov 24, 1997
PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM
K973359 · Richard Wolf Medical Instruments Corp.
GCJ · Laparoscope, General & Plastic Surgery · 77d
Cleared Nov 21, 1997
OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
K973232 · Olympus Winter & Ibe GmbH
GCJ · Laparoscope, General & Plastic Surgery · 85d
Cleared Nov 13, 1997
CYNOSURE PHOTOGENICA ER LASER
K973498 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 59d
Cleared Nov 13, 1997
HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE
K973341 · Richard Wolf Medical Instruments Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 69d
Cleared Nov 13, 1997
ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR
K973139 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 84d
Cleared Nov 07, 1997
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
K973502 · Implantech Associates, Inc.
LZK · Implant, Malar · 52d
Cleared Nov 07, 1997
UNCOATED ELECTROSURGICAL ELECTRODE
K973346 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 63d
Cleared Nov 06, 1997
ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR
K972927 · Richard Wolf Medical Instruments Corp.
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared Oct 29, 1997
COSMAN COAGULATOR (CC-1) SYSTEM
K973297 · Radionics, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 57d
Cleared Oct 29, 1997
POWERSTAR BIPOLAR SCISSORS
K973173 · Ethicon, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 65d
Cleared Oct 24, 1997
DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES
K972471 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 115d
Cleared Oct 24, 1997
AUTO SUTURE BONE WAX
K971680 · United States Surgical, A Division of Tyco Healthc
MTJ · Wax, Bone · 170d
Cleared Oct 01, 1997
REDYROB-CLOSED WOUND DRAINAGE SYSTEM
K972703 · B.Braun Medical, Inc.
GCY · Apparatus, Suction, Single Patient Use, Portable, Nonpowered · 75d
Cleared Oct 01, 1997
ORIGIN LIGATOR DEVICE
K972685 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 76d
Cleared Oct 01, 1997
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
K972578 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 83d
Cleared Oct 01, 1997
CONVATEC ODOR CONTROL WOUND DRESSING
K972530 · Convatec, A Division of E.R. Squibb & Sons
KMF · Bandage, Liquid · 86d

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All categories 7710 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1108 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 222 FTL Mesh, Surgical, Polymeric 186 GDW Staple, Implantable 159 NAY System, Surgical, Computer Controlled Instrument 158 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 120 OMP Negative Pressure Wound Therapy Powered Suction Pump 106 FZP Clip, Implantable 100 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 93 LFL Instrument, Ultrasonic Surgical 85 KGN Wound Dressing With Animal-derived Material(s) 85 GEH Unit, Cryosurgical, Accessories 78