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
13836 General & Plastic Surgery devices
5651–5675 of 13836
Cleared Aug 06, 2010
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
K102001 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 22d
Cleared Aug 04, 2010
NEOTRACT ANCHOR SYSTEM MODEL TAS400
K102028 · Neotract, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 16d
Cleared Jul 30, 2010
ARTHREX BIOWIRE
K091018 · Arthrex, Inc.
GAS · Suture, Nonabsorbable, Synthetic, Polyester · 477d
Cleared Jul 22, 2010
QUANTA DIODE LASER SYSTEM
K100558 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 143d
Cleared Jul 21, 2010
SUPRA SCAN DELIVERY SYSTEM
K100678 · Quantel Medical
GEX · Powered Laser Surgical Instrument · 133d
Cleared Jul 21, 2010
NES REPROCESSED VARICOSE VEIN RF CATHETER
K090661 · Northeast Scientific, Inc.
NUJ · Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed · 496d
Cleared Jul 16, 2010
ERBE ESU MODEL VIO 100 C WITH ACCESSORIES
K101108 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 87d
Cleared Jul 15, 2010
VENTRALIGHT ST MESH
K101851 · Davol Inc., Sub. C. R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 14d
Cleared Jul 15, 2010
NEOTRACT ANCHOR SYSTEM MODEL: REF 11208
K101252 · Neotract, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 72d
Cleared Jul 14, 2010
AESCULAP MONOMAX ABSORBABLE SUTURE
K100876 · Aesculap, Inc.
NWJ · Suture, Recombinant Technology · 106d
Cleared Jul 08, 2010
PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT
K100461 · Riverpoint Medical
NEW · Suture, Surgical, Absorbable, Polydioxanone · 140d
Cleared Jul 01, 2010
PK SUPERPULSE SYSEM GENERATOR MODEL 744000
K100816 · Gyrus Acmi, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 100d
Cleared Jun 30, 2010
HANSON MEDICAL FACIAL IMPLANTS
K090803 · Hanson Medical, Inc.
FZE · Prosthesis, Nose, Internal · 463d
Cleared Jun 29, 2010
A4-XLR8 FOAM DRESSING
K092992 · Genadyne Biotechnologies, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 274d
Cleared Jun 25, 2010
SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
K101671 · Teleflexmedical, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 11d
Cleared Jun 25, 2010
STRYKER KNIFELIGHT
K100884 · Howmedica Osteonics Corp.
FTD · Lamp, Surgical · 87d
Cleared Jun 22, 2010
STRYKER BIPOLAR FORCEPS
K093108 · Stryker Leibinger GmbH & Co KG
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 264d
Cleared Jun 18, 2010
VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214
K100638 · Depuy Mitek, A Johnson & Johnson Company
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 105d
Cleared Jun 17, 2010
GYRUS ACMI HALO PKS CUTTING FORCEPS
K100896 · Gyrus Acmi, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 78d
Cleared Jun 14, 2010
CRYOCARE CS SURGICAL SYSTEM
K101333 · Endocare, Inc.
GEH · Unit, Cryosurgical, Accessories · 33d
Cleared Jun 11, 2010
PREVENA INCISION MANAGEMENT SYSTEM
K100821 · Kci USA, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 80d
Cleared Jun 10, 2010
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
K093679 · AtriCure, Inc.
FZP · Clip, Implantable · 195d
Cleared May 26, 2010
AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES
K090379 · Avita Corporation
BTA · Pump, Portable, Aspiration (manual Or Powered) · 463d
Cleared May 21, 2010
CONMED MACROLYTE DISPERSIVE ELECTRODE
K100686 · Conmed Corporation
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 72d
Cleared May 14, 2010
SUREFIT DUAL DISPERSIVE ELECTRODE
K100047 · Conmed Corporation
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 126d

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All categories 13836 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