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

18256
Total
18211
Cleared
137d
Avg (2y)
1976
Since
7667 General & Plastic Surgery devices
4376–4400 of 7667
Cleared Mar 07, 2003
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000)
K030551 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d
Cleared Mar 07, 2003
VIATORR ENDOPROSTHESIS
K024178 · W.L. Gore & Associates, Inc.
JCT · Prosthesis, Tracheal, Expandable · 79d
Cleared Feb 26, 2003
V.A.C. ABDOMINAL DRESSING
K022011 · Kinetic Concepts, Inc.
FTL · Mesh, Surgical, Polymeric · 252d
Cleared Feb 21, 2003
AUTOCON II 200 ELECTROSURGICAL GENERATOR
K023924 · Karl Storz Endoscopy
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 88d
Cleared Feb 20, 2003
SMALL BARD VENTRALEX PATCH
K024008 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 78d
Cleared Feb 19, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
K023882 · Implex Corp.
EZX · Mesh, Surgical, Metal · 90d
Cleared Feb 10, 2003
POLARIS DS
K024064 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 63d
Cleared Feb 10, 2003
BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
K022856 · Aaron Medical Industries
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 167d
Cleared Feb 03, 2003
ARTHROCARE ENT COBLATOR SURGERY SYSTEM
K030108 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 21d
Cleared Feb 03, 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · Coloplast Corp.
FRO · Dressing, Wound, Drug · 194d
Cleared Jan 30, 2003
KSEA SCB ACC CONTROL
K023704 · KARL STORZ Endoscopy-America, Inc.
FTA · Light, Surgical, Accessories · 87d
Cleared Jan 27, 2003
SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921
K023624 · Surgical Laser Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Jan 27, 2003
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
K022951 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 144d
Cleared Jan 22, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K022884 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 145d
Cleared Jan 17, 2003
BIPOLAR FORCEPS
K023813 · Richard Wolf Medical Instruments Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 63d
Cleared Jan 08, 2003
ERBE VIO APC WITH ACCESSORIES
K024047 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 30d
Cleared Dec 20, 2002
CANDELA GENTLE YAG LASER SYSTEM
K023193 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 86d
Cleared Dec 20, 2002
VACUUM ASSISTED CLOSURE
K021500 · Kinetic Concepts, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 225d
Cleared Dec 19, 2002
STEELEX STERNUM SET
K023411 · Aesculap, Inc.
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 69d
Cleared Dec 19, 2002
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
K022715 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 126d
Cleared Dec 17, 2002
ARTHREX OPES ELECTRODES AND ACCESSORIES
K023986 · Arthrex, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 15d
Cleared Dec 12, 2002
ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D
K023886 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 21d
Cleared Dec 10, 2002
MODIFICATION TO VIABAHN ENDOPROSTHESIS
K023811 · W.L. Gore & Associates, Inc.
JCT · Prosthesis, Tracheal, Expandable · 25d
Cleared Dec 02, 2002
V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT
K021501 · Kinetic Concepts, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 207d
Cleared Nov 29, 2002
NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085
K023812 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d

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All categories 7667 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1106 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 220 FTL Mesh, Surgical, Polymeric 186 GDW Staple, Implantable 159 NAY System, Surgical, Computer Controlled Instrument 158 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 120 OMP Negative Pressure Wound Therapy Powered Suction Pump 101 FZP Clip, Implantable 100 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 93 KGN Wound Dressing With Animal-derived Material(s) 85 LFL Instrument, Ultrasonic Surgical 85 GEH Unit, Cryosurgical, Accessories 78