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
7711 General & Plastic Surgery devices
5001–5025 of 7711
Cleared Dec 31, 1996
OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM
K963184 · Olympus America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 139d
Cleared Dec 18, 1996
MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
K964072 · Ethicon, Inc.
GAN · Suture, Absorbable, Synthetic · 68d
Cleared Dec 16, 1996
ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED
K964345 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 46d
Cleared Dec 16, 1996
CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER
K963094 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 130d
Cleared Dec 12, 1996
CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
K963839 · Cordis Corp.
GCY · Apparatus, Suction, Single Patient Use, Portable, Nonpowered · 79d
Cleared Dec 05, 1996
VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES
K964175 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 48d
Cleared Dec 04, 1996
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K964121 · Boston Scientific Scimed, Inc.
JCT · Prosthesis, Tracheal, Expandable · 50d
Cleared Nov 26, 1996
ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES
K963189 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 104d
Cleared Nov 25, 1996
SUCTION CATHETER TRAY PRODUCT NO. 900277
K964011 · Customed, Inc.
LRO · General Surgery Tray · 49d
Cleared Nov 25, 1996
MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE
K963783 · Ethicon, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 66d
Cleared Nov 21, 1996
ENDO VIP
K963323 · Richard Wolf Medical Instruments Corp.
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared Nov 15, 1996
SURGICAL FABRICS
K963226 · Boston Scientific Corp
FTL · Mesh, Surgical, Polymeric · 88d
Cleared Nov 14, 1996
ULTRAFLEX
K963241 · Boston Scientific Corp
JCT · Prosthesis, Tracheal, Expandable · 87d
Cleared Nov 05, 1996
SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS
K963229 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 78d
Cleared Nov 04, 1996
E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE
K962690 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 116d
Cleared Nov 04, 1996
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
K962584 · Ethicon Endo-Surgery, Inc.
LFL · Instrument, Ultrasonic Surgical · 126d
Cleared Nov 01, 1996
ENDOCAM
K963046 · Corin USA
GCJ · Laparoscope, General & Plastic Surgery · 88d
Cleared Nov 01, 1996
SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER
K961935 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 165d
Cleared Oct 31, 1996
CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS
K962993 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 91d
Cleared Oct 25, 1996
GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
K963619 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 45d
Cleared Oct 25, 1996
ETHICON ENDOSUTURE SYSTEM
K963329 · Ethicon, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 63d
Cleared Oct 25, 1996
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · Smith & Nephew United, Inc.
KMF · Bandage, Liquid · 77d
Cleared Oct 08, 1996
MIRROR FINISH BIPOLAR FORCEPS
K963499 · Johnson & Johnson Professionals, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 35d
Cleared Oct 08, 1996
SYNTHETIC ABSORBABLE SURGICAL SUTURE
K963253 · United States Surgical, A Division of Tyco Healthc
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 50d
Cleared Oct 08, 1996
ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980)
K963123 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 57d

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All categories 7711 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 101 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