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
14092 General & Plastic Surgery devices
9701–9725 of 14092
Cleared Nov 08, 1996
PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)
K963124 · Fisma, Inc.
GEX · Powered Laser Surgical Instrument · 88d
Cleared Nov 05, 1996
DERMAMEND GEL
K962089 · Dermarx Corp.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 160d
Cleared Nov 05, 1996
SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS
K963229 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 78d
Cleared Nov 05, 1996
REUSABLE TROCAR WITH SLEEVE (COMMON)
K963815 · Pilling Weck Group
GCJ · Laparoscope, General & Plastic Surgery · 43d
Cleared Nov 04, 1996
ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
K962584 · Ethicon Endo-Surgery, Inc.
LFL · Instrument, Ultrasonic Surgical · 126d
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
ELECTROSURGICAL PROBE
K963901 · Smith & Nephew Endoscopy, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 38d
Cleared Nov 01, 1996
AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM
K961705 · Applied Optronics Corp.
GEX · Powered Laser Surgical Instrument · 183d
Cleared Nov 01, 1996
AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM
K961710 · Applied Optronics Corp.
GEX · Powered Laser Surgical Instrument · 183d
Cleared Nov 01, 1996
SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER
K961935 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 165d
Cleared Nov 01, 1996
ENDOCAM
K963046 · Corin USA
GCJ · Laparoscope, General & Plastic Surgery · 88d
Cleared Oct 31, 1996
CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS
K962993 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 91d
Cleared Oct 30, 1996
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
K963188 · Codi International BV
EFQ · Gauze/sponge, Internal · 76d
Cleared Oct 30, 1996
BIODERM PVP FOAM WOUND DRESSING
K963602 · Bioderm, Inc.
KMF · Bandage, Liquid · 51d
Cleared Oct 25, 1996
CERALAS G ND
K962948 · Ceram Optec, Inc.
GEX · Powered Laser Surgical Instrument · 88d
Cleared Oct 25, 1996
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · Smith & Nephew United, Inc.
KMF · Bandage, Liquid · 77d
Cleared Oct 25, 1996
ETHICON ENDOSUTURE SYSTEM
K963329 · Ethicon, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 63d
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
SPYROFLEX PIGMENTED WOUND DRESSING
K963623 · Polymedica Industries, Inc.
MGP · Dressing, Wound And Burn, Occlusive · 44d
Cleared Oct 23, 1996
SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)
K963772 · Somnus Medical Technologies, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 34d
Cleared Oct 21, 1996
STAPLE REMOVAL KIT
K963234 · Continental Medical Laboratories, Inc.
GDT · Staple, Removable (skin) · 63d
Cleared Oct 21, 1996
UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
K963338 · Unimed Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 59d
Cleared Oct 17, 1996
PROD. NO. 02-031 - LACERATION TRAY
K963443 · Continental Medical Laboratories, Inc.
LRO · General Surgery Tray · 48d
Cleared Oct 15, 1996
CHONDROPROTEC
K961930 · The Hymed Group Corp.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 151d
Cleared Oct 15, 1996
S-357 VIDEO IMAGING SYSTEM
K962684 · Del Medical Systems Corp.
GCJ · Laparoscope, General & Plastic Surgery · 97d

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All categories 14092 GEX Powered Laser Surgical Instrument 2380 GEI Electrosurgical, Cutting & Coagulation & Accessories 1886 GCJ Laparoscope, General & Plastic Surgery 1117 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