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
14064 General & Plastic Surgery devices
9301–9325 of 14064
Cleared Oct 21, 1997
ALGINATE/ZINC WOUND DRESSING
K973283 · Innovative Technologies , Ltd.
KMF · Bandage, Liquid · 49d
Cleared Oct 21, 1997
KELOCOTE SCAR GEL AND KELOCOTE LASER GEL
K973572 · Hanson Medical, Inc.
MDA · Elastomer, Silicone, For Scar Management · 32d
Cleared Oct 07, 1997
BIPOLAR SCISSORS
K972558 · Enable Medical Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 90d
Cleared Oct 06, 1997
NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY
K972561 · American Laser Medical
GEX · Powered Laser Surgical Instrument · 89d
Cleared Oct 01, 1997
NAVIGATOR (STYLET) 2006
K972521 · Sil-Med Corp.
GAH · Stylet, Surgical, General & Plastic Surgery · 86d
Cleared Oct 01, 1997
CONVATEC ODOR CONTROL WOUND DRESSING
K972530 · Convatec, A Division of E.R. Squibb & Sons
KMF · Bandage, Liquid · 86d
Cleared Oct 01, 1997
ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
K972578 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 83d
Cleared Oct 01, 1997
PMT NEW BEGINNINGS GELSHAPES & AMEND
K972597 · Pmt Corp.
MDA · Elastomer, Silicone, For Scar Management · 82d
Cleared Oct 01, 1997
ULTRACELL SUCTION SPONGE
K972635 · Ultracell Medical Technologies, Inc.
GBX · Catheter, Irrigation · 79d
Cleared Oct 01, 1997
CRYOGEN CRYOSURGICAL SYSTEM
K972662 · Cryogen, Inc.
GEH · Unit, Cryosurgical, Accessories · 90d
Cleared Oct 01, 1997
ORIGIN LIGATOR DEVICE
K972685 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 76d
Cleared Oct 01, 1997
REDYROB-CLOSED WOUND DRAINAGE SYSTEM
K972703 · B.Braun Medical, Inc.
GCY · Apparatus, Suction, Single Patient Use, Portable, Nonpowered · 75d
Cleared Sep 29, 1997
MM-RUBY
K970475 · American Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 234d
Cleared Sep 29, 1997
XOMED T-STENT, FRONTAL SINUS STENT
K973273 · Xomed, Inc.
KAM · Cannula, Sinus · 27d
Cleared Sep 26, 1997
MIST MICRO INTERCHANGEABLE SCOPE SYSTEM (TM)
K970937 · Mist, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 197d
Cleared Sep 25, 1997
UNICA 315 M CO2 SURGICAL LASER SYSTEM
K971821 · Reliant Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 132d
Cleared Sep 25, 1997
ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR
K973159 · Oratec Interventions, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 34d
Cleared Sep 25, 1997
STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS
K973379 · S. Jackson, Inc.
FTM · Mesh, Surgical · 17d
Cleared Sep 23, 1997
MIST PANORAMIC LAPAROSCOPE A RIGID LAPAROSCOPE
K971150 · Mist, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 179d
Cleared Sep 23, 1997
FOTONA SKINLIGHT PLUS ND: YAG SYSTEM
K972368 · Medical Laser Solutions
GEX · Powered Laser Surgical Instrument · 90d
Cleared Sep 19, 1997
PIONEER ELEC-TROCAR DEVICE
K971728 · Pioneer Surgical Technology
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 133d
Cleared Sep 19, 1997
ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS AND ELECTRODES
K972008 · European Surgical, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 112d
Cleared Sep 19, 1997
PULSEMASTER 1000 ST DENTAL LASER SYSTEM
K972325 · American Dental Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 88d
Cleared Sep 19, 1997
MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER
K972347 · Lumenis, Inc.
GEX · Powered Laser Surgical Instrument · 87d
Cleared Sep 19, 1997
MINISITE*BIPOLAR FORCEPS** DEVICE
K972415 · United States Surgical, A Division of Tyco Healthc
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 84d

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All categories 14064 GEX Powered Laser Surgical Instrument 2377 GEI Electrosurgical, Cutting & Coagulation & Accessories 1879 GCJ Laparoscope, General & Plastic Surgery 1116 FRO Dressing, Wound, Drug 575 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 260 GEH Unit, Cryosurgical, Accessories 213 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