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
6001–6025 of 13838
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
Cleared Jan 09, 2009
180W CERELAS D 980NM DIODE LASER, MODEL D180
K083682 · Biolitec, Inc.
GEX · Powered Laser Surgical Instrument · 29d
Cleared Jan 09, 2009
REPROCESSED HARMONIC SCALPEL
K083060 · Sterilmed, Inc.
NLQ · Single-use Reprocessed Ultrasonic Surgical Instruments · 87d
Cleared Jan 08, 2009
MODIFICATION TO ZENIEVA
K083721 · River'S Edge Pharmaceuticals, LLC
NAE · Dressing, Wound, Hydrogel Without Drug And/or Biologic · 24d
Cleared Jan 07, 2009
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
K082941 · Biomerix Corporation
FTL · Mesh, Surgical, Polymeric · 97d
Cleared Jan 02, 2009
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
K082396 · C.R. Bard, Inc.
GDW · Staple, Implantable · 136d
Cleared Jan 02, 2009
A-LAP SET (A-LAP, EZAXESS, TROCAR)
K082291 · Ezsurgical
GCJ · Laparoscope, General & Plastic Surgery · 144d
Cleared Dec 31, 2008
ERBE MODEL VIO 300 D WITH ACCESSORIES
K083452 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 40d
Cleared Dec 29, 2008
WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553
K083355 · Blairex Laboratories, Inc.
FRO · Dressing, Wound, Drug · 46d
Cleared Dec 24, 2008
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
K081060 · Core Essence Orthopaedics, LLC
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 254d
Cleared Dec 23, 2008
FIXATION TROCARS
K083638 · Applied Medical Resources Corp.
GCJ · Laparoscope, General & Plastic Surgery · 14d
Cleared Dec 23, 2008
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
K083613 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 15d
Cleared Dec 22, 2008
NOVEON MODEL LS1100-03
K083476 · Nomir Medical Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 28d
Cleared Dec 22, 2008
EZLASE
K082938 · Biolase Technology, Inc.
GEX · Powered Laser Surgical Instrument · 81d
Cleared Dec 19, 2008
SURGISEAL TOPICAL SKIN ADHESIVE
K082993 · Adhezion Biomedical
MPN · Tissue Adhesive For The Topical Approximation Of Skin · 73d
Cleared Dec 19, 2008
SMOOTHCOOL HR SYSTEM
K082911 · Jeisys Medical, Inc.
GEX · Powered Laser Surgical Instrument · 80d

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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