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
13822 General & Plastic Surgery devices
5701–5725 of 13822
Cleared Feb 26, 2010
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841
K093203 · Medtronic, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 136d
Cleared Feb 24, 2010
VERSAPULSE MODEL P20 LASER SYSTEM
K100228 · Lumenis, Inc.
GEX · Powered Laser Surgical Instrument · 29d
Cleared Feb 23, 2010
MEP-90 HAIR GROWTH STIMULATION SYSTEM
K091496 · Midwest Rf, LLC
OAP · Laser, Comb, Hair · 279d
Cleared Feb 17, 2010
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
K100218 · Coloplast A/S
FRO · Dressing, Wound, Drug · 22d
Cleared Feb 12, 2010
MODIFIED STRAIGHT FIRE LASER FIBER
K100078 · Boston Scientific Corp
GEX · Powered Laser Surgical Instrument · 31d
Cleared Feb 03, 2010
VECTRA PLUS LASER SYSTEM AND ACCESSORIES
K082230 · Xintec Corporation
GEX · Powered Laser Surgical Instrument · 545d
Cleared Jan 28, 2010
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
K092508 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 164d
Cleared Jan 26, 2010
ATRIUM C-QUR OVT MESH
K100076 · Atrium Medical Corp.
FTL · Mesh, Surgical, Polymeric · 14d
Cleared Jan 22, 2010
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID
K093162 · Fotona D.D.
GEX · Powered Laser Surgical Instrument · 108d
Cleared Jan 22, 2010
LAPAROSCOPIC RETRACTORS
K092684 · Cardinal Health, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 143d
Cleared Jan 21, 2010
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
K093217 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 100d
Cleared Jan 15, 2010
ARTHROCARE COBLATOR IQ SYSTEM
K091674 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 220d
Cleared Jan 15, 2010
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
K091259 · Ethicon Endo-Surgery, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 261d
Cleared Jan 14, 2010
MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET
K093519 · Medtrade Products , Ltd.
QSY · Hemostatic Wound Dressing Without Thrombin Or Other Biologics · 62d
Cleared Jan 14, 2010
HYDROCOAT MESH
K090271 · Promethean Surgical Devices, Inc.
FTL · Mesh, Surgical, Polymeric · 344d
Cleared Jan 08, 2010
MATRIX RF APPLICATOR
K090025 · Syneron Medical, Ltd.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 368d
Cleared Jan 08, 2010
DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
K082097 · Demetech Corp.
NEW · Suture, Surgical, Absorbable, Polydioxanone · 533d
Cleared Jan 07, 2010
VARI-LASE ENDOVENOUS LASER CONSOLE
K093502 · Vascular Solutions, Inc.
GEX · Powered Laser Surgical Instrument · 56d
Cleared Jan 07, 2010
MEDLINE CURAD WOUND DRESSINGS
K093349 · Medline Industries, Inc.
FRO · Dressing, Wound, Drug · 72d
Cleared Jan 07, 2010
MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL
K090345 · Conseal International, Inc.
FRO · Dressing, Wound, Drug · 331d
Cleared Jan 05, 2010
TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC
K090312 · Tria Beauty, Inc.
GEX · Powered Laser Surgical Instrument · 333d
Cleared Jan 04, 2010
LIGHTWAVE PROFESSIONAL DELUXE
K082586 · Lightwave Technologies, LLC
GEX · Powered Laser Surgical Instrument · 483d
Cleared Dec 29, 2009
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
K091585 · Kci USA, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 210d
Cleared Dec 23, 2009
TRIA HAIR REMOVAL LASER SYSTEM
K090820 · Spectragenics, Inc.
GEX · Powered Laser Surgical Instrument · 272d
Cleared Dec 18, 2009
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
K092483 · C.R. Bard, Inc.
GDW · Staple, Implantable · 127d

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All categories 13822 GEX Powered Laser Surgical Instrument 2353 GEI Electrosurgical, Cutting & Coagulation & Accessories 1842 GCJ Laparoscope, General & Plastic Surgery 1091 FRO Dressing, Wound, Drug 541 FTL Mesh, Surgical, Polymeric 307 GDW Staple, Implantable 251 GEH Unit, Cryosurgical, Accessories 209 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