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
5976–6000 of 13838
Cleared Feb 09, 2009
BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER
K083006 · Biopsy Sciences, LLC
NEU · Marker, Radiographic, Implantable · 124d
Cleared Feb 06, 2009
INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES
K090159 · Incisive Surgical, Inc.
GDW · Staple, Implantable · 15d
Cleared Feb 06, 2009
AWBAT-S, AWBAT-D, AWBAT-M
K082869 · Aubrey, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 130d
Cleared Feb 06, 2009
ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM
K082825 · Energist, Ltd.
GEX · Powered Laser Surgical Instrument · 134d
Cleared Feb 06, 2009
ADVANCED MEDICAL INNOVATIONS DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES
K081398 · Advanced Medical Innovations, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 263d
Cleared Feb 04, 2009
SURGIMEND
K083898 · Tei Biosciences, Inc.
FTM · Mesh, Surgical · 37d
Cleared Feb 04, 2009
EEA HEMORRHOID STAPLER & ACCESSORIES
K083781 · Surgical Devices, A Global Business Unit Covidien
GDW · Staple, Implantable · 47d
Cleared Feb 04, 2009
FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F
K083034 · Fotona D.D.
GEX · Powered Laser Surgical Instrument · 117d
Cleared Feb 04, 2009
GELX ORAL GEL
K081372 · Bmg Pharma, LLC
OLR · Oral Wound Dressing · 264d
Cleared Feb 04, 2009
IRRISEPT WOUND CLEANSING SYSTEM
K080779 · Irrimax Corporation
FQH · Lavage, Jet · 322d
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

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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