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
13853 General & Plastic Surgery devices
6001–6025 of 13853
Cleared Feb 03, 2009
MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
K082407 · Sandstone Medical Technologies, LLC
GEX · Powered Laser Surgical Instrument · 166d
Cleared Feb 02, 2009
ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250
K083918 · Advanced Technology Laser Co., Ltd.
GEX · Powered Laser Surgical Instrument · 34d
Cleared Feb 02, 2009
IPULSE, MODEL: I150
K083748 · Cyden Limited
GEX · Powered Laser Surgical Instrument · 47d
Cleared Feb 02, 2009
MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34
K083711 · Barrx Medical, Incorporated
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 49d
Cleared Jan 30, 2009
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
K083258 · Dornier Medtech America, Inc.
GEX · Powered Laser Surgical Instrument · 87d
Cleared Jan 29, 2009
ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC
K083915 · Advanced Technology Laser Co., Ltd.
GEX · Powered Laser Surgical Instrument · 30d
Cleared Jan 29, 2009
RELIEVA STRATUS MICROFLOW SPACER
K083574 · Acclarent, Inc.
KAM · Cannula, Sinus · 57d
Cleared Jan 28, 2009
SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022
K083528 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 61d
Cleared Jan 28, 2009
NUVO VERDE LED LIGHTING SYSTEM
K083323 · Nuvo, Inc.
FSY · Light, Surgical, Ceiling Mounted · 77d
Cleared Jan 26, 2009
BEAU RX SCAR CARE GEL
K083718 · Beau RX Solutions, LLC
MDA · Elastomer, Silicone, For Scar Management · 42d
Cleared Jan 22, 2009
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026
K083856 · Relievant Medsystems, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d
Cleared Jan 21, 2009
CYNOSURE SMARTLIPO MPX LASER
K083795 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 30d
Cleared Jan 21, 2009
SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083
K082409 · Endophotonix, Inc.
GEX · Powered Laser Surgical Instrument · 153d
Cleared Jan 16, 2009
VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
K083194 · Terumo Cardiovascular Systems Corp.
GCJ · Laparoscope, General & Plastic Surgery · 79d
Cleared Jan 16, 2009
DUAL NEEDLE SUTURE PASSER SYSTEM
K082518 · Cayenne Medical, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 136d
Cleared Jan 16, 2009
OMNILUX CLEAR-U
K081307 · Photo Therapeutics, Inc.
OLP · Over-the-counter Powered Light Based Laser For Acne · 253d
Cleared Jan 15, 2009
MODIFICATION TO MEDWAVES MICROWAVE COAGULATION/ABLATION SYSTEM
K083537 · Medwaves Incorporated
NEY · System, Ablation, Microwave And Accessories · 48d
Cleared Jan 15, 2009
ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505
K082955 · Ethicon Endo-Surgery, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 104d
Cleared Jan 15, 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377 · Nuvasive, Inc.
FTL · Mesh, Surgical, Polymeric · 244d
Cleared Jan 14, 2009
ATRIUM PROLITE S MESH
K082748 · Atrium Medical Corp.
FTL · Mesh, Surgical, Polymeric · 117d
Cleared Jan 13, 2009
MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS
K083082 · Moor Instruments, Ltd.
GEX · Powered Laser Surgical Instrument · 89d
Cleared Jan 13, 2009
PRUMYX CREAM
K082089 · Prugen, Inc.
FRO · Dressing, Wound, Drug · 173d
Cleared Jan 12, 2009
STINGRAY ELECTROSURGICAL FORCEPS
K083162 · Stingray Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 77d
Cleared Jan 12, 2009
ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE
K082622 · Alma Lasers , Ltd.
NUV · Massager, Vacuum, Light Induced Heating · 125d
Cleared Jan 09, 2009
ISOLAZ
K083730 · Aesthera Corporation
GEX · Powered Laser Surgical Instrument · 24d

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All categories 13853 GEX Powered Laser Surgical Instrument 2357 GEI Electrosurgical, Cutting & Coagulation & Accessories 1847 GCJ Laparoscope, General & Plastic Surgery 1095 FRO Dressing, Wound, Drug 548 FTL Mesh, Surgical, Polymeric 309 GDW Staple, Implantable 252 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 207 KGN Wound Dressing With Animal-derived Material(s) 168 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 154 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 153