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
6051–6075 of 13853
Cleared Dec 16, 2008
SKINCLEAR Q-SWITCHED ND:YAG LASER
K083272 · Global USA Distribution, LLC
GEX · Powered Laser Surgical Instrument · 40d
Cleared Dec 16, 2008
MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
K082278 · Ethicon Endo-Sugery, LLC
NEU · Marker, Radiographic, Implantable · 127d
Cleared Dec 16, 2008
MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
K080741 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 274d
Cleared Dec 15, 2008
AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
K083211 · Surgiquest, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 45d
Cleared Dec 12, 2008
PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440 · Tei Biosciences, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 22d
Cleared Dec 12, 2008
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
K083379 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 28d
Cleared Dec 12, 2008
PROLITE III TOWER AND PR AND HR HANDPIECE
K081095 · Quantel S.A.
GEX · Powered Laser Surgical Instrument · 239d
Cleared Dec 10, 2008
MODIFICATION TO ARTHROCARE ARTHROWANDS
K083306 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 30d
Cleared Dec 10, 2008
RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES
K082902 · Rz Medizintechnik GmbH
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 71d
Cleared Dec 09, 2008
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001
K083013 · Gyrus Acmi, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 61d
Cleared Dec 04, 2008
TIVAMED COOLED RF SYSTEM, MODEL 78001
K082962 · Tivamed, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 62d
Cleared Dec 04, 2008
LIPOSE FAT TRANSFER SYSTEM
K081848 · Lipose Corp.
MUU · System, Suction, Lipoplasty · 157d
Cleared Dec 04, 2008
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · Integra Lifesciences Corp.
KGN · Wound Dressing With Animal-derived Material(s) · 176d
Cleared Dec 03, 2008
PULSAR GENERATOR, PEAK PLASMABLADE
K082786 · Peak Surgical, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 71d
Cleared Dec 03, 2008
NO!NO! SKIN
K082423 · Radiancy (Israel) , Ltd.
GEX · Powered Laser Surgical Instrument · 103d
Cleared Dec 03, 2008
15W CERALAS D 1470NM DIODE LASER, MODEL D1470
K082225 · Biolitec, Inc.
GEX · Powered Laser Surgical Instrument · 119d
Cleared Dec 01, 2008
COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
K082535 · Surgical Devices, A Global Business Unit Covidien
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 90d
Cleared Dec 01, 2008
DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
K082208 · Scivolutions, Inc.
NAC · Dressing, Wound, Hydrophilic · 118d
Cleared Dec 01, 2008
PROSIT WOUND TREATMENT DEVICE
K081977 · Silverleaf Medical Products, Inc.
FRO · Dressing, Wound, Drug · 143d
Cleared Nov 26, 2008
VERITAS COLLAGEN MATRIX (DRY)
K083039 · Synovis Surgical Innovations
FTM · Mesh, Surgical · 43d
Cleared Nov 25, 2008
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
K082415 · Premco Medical Systems, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 96d
Cleared Nov 25, 2008
VALLEYLAB MICROWAVE ABLATION GENERATOR
K072687 · Covidien Lp, Formerly Know AS Valleylab, A Divison
NEY · System, Ablation, Microwave And Accessories · 428d
Cleared Nov 21, 2008
REXASTOM ORAL EASE
K082553 · Rexaderm, Inc.
OLR · Oral Wound Dressing · 79d
Cleared Nov 21, 2008
VERTEBRAL ACCESS SYSTEM BY VIDACARE
K081713 · Vidacare Corporation
MOQ · Battery, Replacement, Rechargeable · 157d
Cleared Nov 20, 2008
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM
K082284 · Alveolus, Inc.
JCT · Prosthesis, Tracheal, Expandable · 101d

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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