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
13838 General & Plastic Surgery devices
5951–5975 of 13838
Cleared Feb 27, 2009
ERBIUM FRACTIONAL HANDPIECE
K083900 · Palomar Medical Products, Inc.
GEX · Powered Laser Surgical Instrument · 60d
Cleared Feb 27, 2009
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
K082682 · Cook Biotech, Inc.
FTM · Mesh, Surgical · 165d
Cleared Feb 26, 2009
SILVER ALGINATE 11 WOUND DRESSING
K090453 · Advanced Medical Solutions Limited
FRO · Dressing, Wound, Drug · 3d
Cleared Feb 26, 2009
LH-75T PHOTOTHERAPY SYSTEM
K090097 · Lerner Medical Devices, Inc.
FTC · Light, Ultraviolet, Dermatological · 42d
Cleared Feb 26, 2009
ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
K083103 · Acrymed, Inc.
FRO · Dressing, Wound, Drug · 129d
Cleared Feb 26, 2009
COPA AMD
K082296 · Covidien Lp, Formerly Registered AS Tyco Healthcar
FRO · Dressing, Wound, Drug · 198d
Cleared Feb 25, 2009
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 103d
Cleared Feb 25, 2009
EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-
K083281 · Linvatec Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 110d
Not Cleared Feb 25, 2009
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
DEN070002 · Quick-Med Technologies, Inc.
NYS · Wound Dressing With Poly(diallyl Dimethyl Ammonium Chloride)(pdadmac) · 657d
Cleared Feb 23, 2009
CHROMOPHARE E 668
K090378 · Berchtold GmbH & Co. KG
FSY · Light, Surgical, Ceiling Mounted · 6d
Cleared Feb 23, 2009
GLUSEAL 90, MODEL GLU9010
K083752 · Glustitch, Inc.
KMF · Bandage, Liquid · 68d
Cleared Feb 23, 2009
RETRACTOR LITE
K083710 · Thomas Surgical Instruments, Inc.
FST · Light, Surgical, Fiberoptic · 70d
Cleared Feb 23, 2009
DERMABLATE EFFECT
K081541 · Asclepion Laser Technologies GmbH
GEX · Powered Laser Surgical Instrument · 266d
Cleared Feb 19, 2009
SMOOTHSHAPES
K083629 · Eleme Medical, Inc.
NUV · Massager, Vacuum, Light Induced Heating · 73d
Cleared Feb 18, 2009
GELPORT SINGLE INCISION ACCESS SYSTEM
K090275 · Applied Medical Resources Corp.
GCJ · Laparoscope, General & Plastic Surgery · 14d
Cleared Feb 18, 2009
AXXION LIGHT GUIDE
K082992 · Spinal Elements, Inc.
FST · Light, Surgical, Fiberoptic · 134d
Cleared Feb 18, 2009
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
K081137 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 303d
Cleared Feb 13, 2009
PALOMAR ASPIRE LASER PLATFORM
K083165 · Palomar Medical Products, Inc.
GEX · Powered Laser Surgical Instrument · 109d
Cleared Feb 12, 2009
LIQUIBAND ULTIMA, MODEL LB0004
K083531 · Medlogic Global , Ltd.
MPN · Tissue Adhesive For The Topical Approximation Of Skin · 76d
Cleared Feb 12, 2009
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
K083500 · Dornier Medtech America, Inc.
GEX · Powered Laser Surgical Instrument · 79d
Cleared Feb 12, 2009
MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-200
K082565 · Microsurgeon, Inc.
NEY · System, Ablation, Microwave And Accessories · 161d
Cleared Feb 11, 2009
WATERLASE MD
K090181 · Biolase Technology, Inc.
GEX · Powered Laser Surgical Instrument · 16d
Cleared Feb 11, 2009
KERATEC WOUND DRESSINGS
K080949 · Keratec Limited
FRO · Dressing, Wound, Drug · 314d
Cleared Feb 10, 2009
HALO ABLATION CATHETER
K083737 · Barrx Medical, Incorporated
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 56d
Cleared Feb 10, 2009
PRO QR ADVANCED FORMULA POWDER
K080210 · Biolife, LLC
QSY · Hemostatic Wound Dressing Without Thrombin Or Other Biologics · 379d

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All categories 13838 GEX Powered Laser Surgical Instrument 2356 GEI Electrosurgical, Cutting & Coagulation & Accessories 1844 GCJ Laparoscope, General & Plastic Surgery 1095 FRO Dressing, Wound, Drug 543 FTL Mesh, Surgical, Polymeric 307 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) 167 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