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
14000 General & Plastic Surgery devices
7876–7900 of 14000
Cleared Jan 15, 2003
AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
K023482 · Kirwan Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 90d
Cleared Jan 13, 2003
VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
K023464 · Quantel Medical
GEX · Powered Laser Surgical Instrument · 90d
Cleared Jan 08, 2003
ERBE VIO APC WITH ACCESSORIES
K024047 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 30d
Cleared Jan 08, 2003
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K024294 · Computer Motion, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 15d
Cleared Jan 02, 2003
CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25
K024088 · Biolitec, Inc.
GEX · Powered Laser Surgical Instrument · 22d
Cleared Dec 31, 2002
PROFILE 1320 LASER SYSTEM
K022466 · Sciton, Inc
GEX · Powered Laser Surgical Instrument · 159d
Cleared Dec 30, 2002
ACELL UBM HYDRATED WOUND DRESSING
K022854 · Acell, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 137d
Cleared Dec 24, 2002
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160
K023962 · New Star Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 25d
Cleared Dec 20, 2002
VACUUM ASSISTED CLOSURE
K021500 · Kinetic Concepts, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 225d
Cleared Dec 20, 2002
CANDELA GENTLE YAG LASER SYSTEM
K023193 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 86d
Cleared Dec 19, 2002
ACELL UBM LYOPHILIZED WOUND DRESSING
K021637 · Acell, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 216d
Cleared Dec 19, 2002
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
K022715 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 126d
Cleared Dec 19, 2002
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
K023280 · Olympus Optical Co., Ltd.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 79d
Cleared Dec 19, 2002
STEELEX STERNUM SET
K023411 · Aesculap, Inc.
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 69d
Cleared Dec 19, 2002
BIOPSY SITE TISSUE MARKER DEVICE
K023450 · Promex, Inc.
NEU · Marker, Radiographic, Implantable · 65d
Cleared Dec 17, 2002
ARTHREX OPES ELECTRODES AND ACCESSORIES
K023986 · Arthrex, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 15d
Cleared Dec 13, 2002
ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
K023261 · Taut, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 74d
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 09, 2002
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V
K022313 · Power Medical Interventions, Inc.
GDW · Staple, Implantable · 145d
Cleared Dec 09, 2002
AMSINO TRACHEOSTOMY CARE TRAY
K023276 · Amsino International, Inc.
LRO · General Surgery Tray · 69d
Cleared Dec 06, 2002
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
K021548 · Fotona D.D.
GEX · Powered Laser Surgical Instrument · 207d
Cleared Dec 05, 2002
CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20
K023757 · Endocare, Inc.
GEH · Unit, Cryosurgical, Accessories · 27d
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
UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES
K023767 · The Olympus Optical Co.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 17d

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All categories 14000 GEX Powered Laser Surgical Instrument 2371 GEI Electrosurgical, Cutting & Coagulation & Accessories 1869 GCJ Laparoscope, General & Plastic Surgery 1113 FRO Dressing, Wound, Drug 569 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 257 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 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 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 157 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155