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
14090 General & Plastic Surgery devices
9351–9375 of 14090
Cleared Sep 19, 1997
MINISITE*BIPOLAR FORCEPS** DEVICE
K972415 · United States Surgical, A Division of Tyco Healthc
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 84d
Cleared Sep 19, 1997
LYOCELL WOUND DRESSING/SURGICAL SPONGE
K972458 · Courtaulds Fibers, Inc.
MGP · Dressing, Wound And Burn, Occlusive · 80d
Cleared Sep 19, 1997
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
K972679 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 65d
Cleared Sep 19, 1997
AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD
K972901 · American Biosurgical, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 44d
Cleared Sep 19, 1997
LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS
K972958 · Lysonix, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 39d
Cleared Sep 18, 1997
MODEL 20 BIPOLAR COAGULATOR
K972311 · Boston Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 90d
Cleared Sep 16, 1997
OPPORTUNITY INCISION AND DRAINAGE TRAY
K971088 · Opportunity, Inc.
EFQ · Gauze/sponge, Internal · 176d
Cleared Sep 16, 1997
OPPORTUNITY DRESSING CHANGE TRAY
K971090 · Opportunity, Inc.
KMF · Bandage, Liquid · 176d
Cleared Sep 16, 1997
OPPURTUNITY TRACHEOSTOMY CARE KIT
K971091 · Opportunity, Inc.
KMF · Bandage, Liquid · 176d
Cleared Sep 16, 1997
OPPORTUNITY I.V. START KIT
K971093 · Opportunity, Inc.
MGP · Dressing, Wound And Burn, Occlusive · 176d
Cleared Sep 16, 1997
OPPORTUNITY SUTURE REMOVAL KIT
K971095 · Opportunity, Inc.
EFQ · Gauze/sponge, Internal · 176d
Cleared Sep 11, 1997
MICROMARK CLIP
K970817 · Biopsys Medical, Inc.
GDW · Staple, Implantable · 189d
Cleared Sep 10, 1997
PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
K972412 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 76d
Cleared Sep 09, 1997
SHOE COVER
K972227 · American Seal Co.
FYF · Cap, Surgical · 88d
Cleared Sep 08, 1997
GRASPING FORCEPS, RIGHT AND LEFT CURVED
K972519 · Richard Wolf Medical Instruments Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 63d
Cleared Sep 05, 1997
MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER
K970808 · Continuum Biomedical, Inc.
GEX · Powered Laser Surgical Instrument · 184d
Cleared Sep 05, 1997
UNISURGE INTERFACE P
K972178 · Unisurge Holding, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 87d
Cleared Sep 04, 1997
RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000
K972441 · Radiotherapeutics Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 66d
Cleared Aug 29, 1997
LIFETECH CASSETTE
K960756 · Lifetech Systems, Inc.
KPJ · Chamber, Oxygen, Topical, Extremity · 553d
Cleared Aug 27, 1997
MODEL I 100 RF PASSIVE ATTENUATOR/SPLITTER AND MODEL QL 10 LOOP ELECTRODE
K964779 · Quantum Loop, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 273d
Cleared Aug 27, 1997
CYNOSURE DERMATOLOGY LASER COOLING TIP
K972002 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 89d
Cleared Aug 27, 1997
SHARPLAN EPITOUCH RUBY LASER SYSTEM
K972099 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 84d
Cleared Aug 27, 1997
BERGEN MODEL 500 ELECTROSURGERY GENERATOR
K972299 · Bergen Mfg.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 69d
Cleared Aug 27, 1997
KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES
K972497 · KARL STORZ Endoscopy-America, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 55d
Cleared Aug 27, 1997
THERMOGARD & THERMOGARD PLUS ABC
K972628 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 44d

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All categories 14090 GEX Powered Laser Surgical Instrument 2380 GEI Electrosurgical, Cutting & Coagulation & Accessories 1886 GCJ Laparoscope, General & Plastic Surgery 1117 FRO Dressing, Wound, Drug 577 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 261 GEH Unit, Cryosurgical, Accessories 214 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 KGN Wound Dressing With Animal-derived Material(s) 172 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 161 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155