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

18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
14094 General & Plastic Surgery devices
9801–9825 of 14094
Cleared Aug 02, 1996
COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED
K962480 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 37d
Cleared Jul 30, 1996
DRAGER GEMINA WALL-MOUNTED WORKPLACE
K961886 · Alm Surgical Equipment, Inc.
FQO · Table, Operating-room, Ac-powered · 76d
Cleared Jul 29, 1996
PROTEC STERILE GAUZE SPONGE
K961773 · Derivadas Degasa S.A. DE C.V.
EFQ · Gauze/sponge, Internal · 82d
Cleared Jul 29, 1996
POLYESTER NONABSORBABLE SURGICAL SUTURES USP
K961925 · R. K. Medical L. L. C.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 73d
Cleared Jul 29, 1996
PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
K961931 · R. K. Medical L. L. C.
GAL · Suture, Absorbable, Natural · 73d
Cleared Jul 26, 1996
WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL, TRIANGULAR GROUND, SAFETY W/OUT LOCK, SET OF SUCTION - IRRIGA0
K955792 · Wilo Medizintechnik Lothar Wilberg GmbH
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 217d
Cleared Jul 26, 1996
DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM
K961742 · Alm Surgical Equipment, Inc.
FQO · Table, Operating-room, Ac-powered · 81d
Cleared Jul 26, 1996
MEDLITE/ERBIUM LASER SYSTEM
K961748 · Continuum Biomedical, Inc.
GEX · Powered Laser Surgical Instrument · 81d
Cleared Jul 24, 1996
MEDLINE TITANIUM HEMOCLIPS
K962016 · Medline Industries, Inc.
FZP · Clip, Implantable · 62d
Cleared Jul 19, 1996
3D SCOPE
K961182 · Oktas
GCJ · Laparoscope, General & Plastic Surgery · 115d
Cleared Jul 19, 1996
ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION
K961264 · Ethicon Endo-Surgery, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 108d
Cleared Jul 19, 1996
MD TECH BIOPSY SET FOR BONE AND BONE MARROW
K961959 · Medical Device Technologies, Inc.
GAA · Needle, Aspiration And Injection, Disposable · 60d
Cleared Jul 18, 1996
BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE
K961505 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 90d
Cleared Jul 16, 1996
PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
K961775 · Smith & Nephew United, Inc.
EFQ · Gauze/sponge, Internal · 69d
Cleared Jul 16, 1996
USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE
K961997 · United States Surgical, A Division of Tyco Healthc
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 55d
Cleared Jul 15, 1996
WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
K961316 · Renaissance Pharmaceutical, Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 101d
Cleared Jul 15, 1996
WOUND HYDROGEL & STERILE WOUND HYDROGEL
K961766 · Renaissance Pharmaceutical, Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 73d
Cleared Jul 11, 1996
SYSTEM 6500 ABC ELECTROSURGICAL UNIT
K955834 · Aspen Laboratories, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 198d
Cleared Jul 11, 1996
CARASYN HYDROGEL WOUND PRODUCTS
K961758 · Carrington Laboratories, Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 69d
Cleared Jul 11, 1996
SORBCEL ALGINATE/CMC WOUND DRESSING
K962421 · Innovative Technologies , Ltd.
KMF · Bandage, Liquid · 17d
Cleared Jul 10, 1996
SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE
K961133 · Somnus Medical Technologies, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 111d
Cleared Jul 10, 1996
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961296 · Boston Scientific Scimed, Inc.
JCT · Prosthesis, Tracheal, Expandable · 97d
Cleared Jul 10, 1996
WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961507 · Boston Scientific Scimed, Inc.
JCT · Prosthesis, Tracheal, Expandable · 82d
Cleared Jul 10, 1996
INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP
K961940 · Innerdyne, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 51d
Cleared Jul 09, 1996
RD-1200H NORMAL MODE RUBY LASER SYSTEM
K955612 · Spectrum Medical Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 214d

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All categories 14094 GEX Powered Laser Surgical Instrument 2380 GEI Electrosurgical, Cutting & Coagulation & Accessories 1886 GCJ Laparoscope, General & Plastic Surgery 1118 FRO Dressing, Wound, Drug 577 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 261 GEH Unit, Cryosurgical, Accessories 214 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 KGN Wound Dressing With Animal-derived Material(s) 172 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 161 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155