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
14005 General & Plastic Surgery devices
7951–7975 of 14005
Cleared Aug 23, 2002
BARD CRURASOFT PATCH, MODELS 0116003 & 0116001
K022350 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 35d
Cleared Aug 21, 2002
DORNIER MEDILAS H LASER FIBER CABLES
K022544 · Dornier Medtech America, Inc.
GEX · Powered Laser Surgical Instrument · 20d
Cleared Aug 19, 2002
DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS
K021724 · Dornier Medtech America, Inc.
GEX · Powered Laser Surgical Instrument · 87d
Cleared Aug 16, 2002
ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER
K021650 · Quantel Medical
GEX · Powered Laser Surgical Instrument · 88d
Cleared Aug 14, 2002
BILAYER MATRIX WOUND DRESSING
K021792 · Integra Lifesciences Corp.
KGN · Wound Dressing With Animal-derived Material(s) · 75d
Cleared Aug 13, 2002
CERALAS D DIODE LASER SYSTEM, MODEL # D50
K013691 · Biolitec, Inc.
GEX · Powered Laser Surgical Instrument · 279d
Cleared Aug 08, 2002
ADAPT OPEN ACCESS PORT, MODEL 41233
K021731 · Taut, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 76d
Cleared Aug 02, 2002
BONESOURCE HAC
K021440 · Stryker Instruments
GXP · Methyl Methacrylate For Cranioplasty · 88d
Cleared Jul 16, 2002
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
K012018 · Acmi Corporation
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 383d
Cleared Jul 16, 2002
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
K021736 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 49d
Cleared Jul 11, 2002
COBRA CARDIAC ELECTROSURGICAL SYSTEM
K013873 · Boston Scientific Corp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 232d
Cleared Jul 11, 2002
AARON A950 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A950 ELECTROSURGICAL GENERATOR, 240V
K021817 · Aaron Medical Industries
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 38d
Cleared Jul 09, 2002
AURORA DS
K021149 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Jul 09, 2002
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
K021901 · Boston Scientific Scimed, Inc.
JCT · Prosthesis, Tracheal, Expandable · 29d
Cleared Jul 03, 2002
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
K021261 · Galil Medical , Ltd.
GEH · Unit, Cryosurgical, Accessories · 75d
Cleared Jul 02, 2002
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
K020021 · Laserscope
GEX · Powered Laser Surgical Instrument · 180d
Cleared Jul 02, 2002
CANDELA VBEAM PULSED DYE LASER SYSTEM
K021180 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 78d
Cleared Jul 01, 2002
ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX
K021079 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 89d
Cleared Jun 26, 2002
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
K021036 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 86d
Cleared Jun 26, 2002
CONMED HEATWAVE HAND-CONTROLLED ELETRODE
K021299 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 63d
Cleared Jun 21, 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · Convatec, A Division of E.R. Squibb & Sons
FRO · Dressing, Wound, Drug · 217d
Cleared Jun 21, 2002
CANDELA CBEAM PULSED DYE LASER SYSTEM
K020958 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 88d
Cleared Jun 21, 2002
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
K021701 · Power Medical Interventions, Inc.
GDW · Staple, Implantable · 29d
Cleared Jun 18, 2002
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
K021019 · Genzyme Corp.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 81d
Cleared Jun 14, 2002
SOPRO LIGHT SOURCES AND ACCESSORIES
K020915 · Sopro
GCJ · Laparoscope, General & Plastic Surgery · 85d

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All categories 14005 GEX Powered Laser Surgical Instrument 2372 GEI Electrosurgical, Cutting & Coagulation & Accessories 1869 GCJ Laparoscope, General & Plastic Surgery 1113 FRO Dressing, Wound, Drug 570 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 257 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 GEH Unit, Cryosurgical, Accessories 210 KGN Wound Dressing With Animal-derived Material(s) 170 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 159 EFQ Gauze/sponge, Internal 157 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 157 KMF Bandage, Liquid 155