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
7713 General & Plastic Surgery devices
5526–5550 of 7713
Cleared Feb 15, 1994
ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED
K920978 · Ethicon, Inc.
GAN · Suture, Absorbable, Synthetic · 715d
Cleared Feb 12, 1994
VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET
K926481 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 410d
Cleared Feb 10, 1994
INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION
K934338 · Innovasive Devices, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 156d
Cleared Feb 10, 1994
SOFTTOUCH II LANCET DEVICE
K931258 · Boehringer Mannheim Corp.
FMK · Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature · 335d
Cleared Feb 10, 1994
LUNG RETRACTORS: DAVIDSON, SEMB
K930316 · Thomasville Medical Assoc.
GAD · Retractor · 384d
Cleared Feb 09, 1994
E-Z PREP(R) TRAY WITH HIBICLENS(R)
K935483 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LRO · General Surgery Tray · 86d
Cleared Feb 09, 1994
CANDELA PLTL-1 LASER SYSTEM
K933016 · Candela Laser Corp.
GEX · Powered Laser Surgical Instrument · 233d
Cleared Feb 09, 1994
NU-GEL ISLAND WOUND DRESSING
K932336 · Johnson & Johnson Medical, Inc.
NAE · Dressing, Wound, Hydrogel Without Drug And/or Biologic · 271d
Cleared Feb 07, 1994
STERILE LAPAROTOMY SPONGES
K934971 · Medsurg Industries, Inc.
GDY · Gauze/sponge, Internal, X-ray Detectable · 112d
Cleared Feb 07, 1994
I SIGHT 2020 ENDOSCOPIC & SURGICAL VIDEO CAMERA
K934097 · Sharplan Lasers, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 168d
Cleared Feb 04, 1994
LAPAROSCOPIC TROCAR STARTER SCALPEL
K936154 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GCJ · Laparoscope, General & Plastic Surgery · 39d
Cleared Feb 04, 1994
EPISEAL ADHESIVE WOUND CLOSURE STRIPS
K935725 · Deroyal Industries, Inc.
KGX · Tape And Bandage, Adhesive · 65d
Cleared Feb 04, 1994
THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE
K930315 · Thomasville Medical Assoc.
GDJ · Clamp, Surgical, General & Plastic Surgery · 378d
Cleared Feb 03, 1994
CICA-CARE SILICONE GEL SHEET
K935803 · Smith & Nephew United, Inc.
MDA · Elastomer, Silicone, For Scar Management · 63d
Cleared Feb 03, 1994
LAPAROSCOPIC RETRACTOR
K933075 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 225d
Cleared Feb 03, 1994
CONBIO CUB-D10 COPPER LASER SYSTEM
K932723 · Buckman Co., Inc.
GEX · Powered Laser Surgical Instrument · 244d
Cleared Feb 03, 1994
FASCIAL CLOSURE DEVICE
K931522 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 314d
Cleared Feb 01, 1994
SERIES 8920 TROCAR SYSTEM
K932441 · Richard Wolf Medical Instruments Corp.
GCJ · Laparoscope, General & Plastic Surgery · 257d
Cleared Jan 31, 1994
AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE
K935762 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 66d
Cleared Jan 31, 1994
NON-INSULATED SCISSORS
K935073 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 98d
Cleared Jan 28, 1994
GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH
K930822 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 345d
Cleared Jan 27, 1994
PROBES,SCISSORS,FORCEPS,GRASPERS,&NEEDLE HOLDERS
K933067 · Medline Industries, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 219d
Cleared Jan 26, 1994
PREPERITONEAL DISTENTION BALLOON SYSTEM
K935426 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 77d
Cleared Jan 26, 1994
OSCILLATING BONE SAW BLADE, 6200 SERIES
K934390 · Boehringer Laboratories
GFA · Blade, Saw, General & Plastic Surgery, Surgical · 139d
Cleared Jan 26, 1994
5MM CALIBRATED SUCTION CANNULA
K934158 · Phx Technologies Corp.
GCJ · Laparoscope, General & Plastic Surgery · 155d

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All categories 7713 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