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
7713 General & Plastic Surgery devices
5626–5650 of 7713
Cleared Oct 28, 1993
DUODERM HYDROACTIVE DRESSING
K925993 · Convatec, A Division of E.R. Squibb & Sons
KMF · Bandage, Liquid · 337d
Cleared Oct 28, 1993
DUODERM CGF CONTROL GEL FORMULA DRESSING & BORDER
K925991 · Convatec, A Division of E.R. Squibb & Sons
KMF · Bandage, Liquid · 337d
Cleared Oct 28, 1993
DUODERM EXTRA THIN CGF DRESSING
K925990 · Convatec, A Division of E.R. Squibb & Sons
KMF · Bandage, Liquid · 337d
Cleared Oct 19, 1993
BABISTICK
K933365 · Graphic Controls Corp.
FMK · Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature · 102d
Cleared Oct 15, 1993
ZEISS OPMILAS 144 SURGICAL LASERS
K933322 · Carl Zeiss, Inc.
GEX · Powered Laser Surgical Instrument · 100d
Cleared Oct 15, 1993
CUTO(TM) TISSUE MORCELLATION SYSTEM
K932700 · Linvatec Corp.
GEY · Motor, Surgical Instrument, Ac-powered · 134d
Cleared Oct 15, 1993
LAPAROSCOPIC BALLOON RETRACTOR
K926480 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 290d
Cleared Oct 15, 1993
REFLEX ESI
K926297 · Richard-Allan Medical Ind., Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 305d
Cleared Oct 15, 1993
ORC ENDOSCOPIC MONOPOLAR ELECTROSURGICAL PROBE
K926242 · O.R. Concepts, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 308d
Cleared Oct 12, 1993
CV720-727-000, MICROTIP AND FLUE PAK
K933239 · Valleylab, Inc.
LFL · Instrument, Ultrasonic Surgical · 102d
Cleared Oct 12, 1993
TECH-SWITCH ELECTROSURGICAL PENCIL, REUSABLE
K932518 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 140d
Cleared Oct 12, 1993
STRYKER STAPLER SYSTEM
K931103 · Stryker Endoscopy
GDW · Staple, Implantable · 223d
Cleared Oct 12, 1993
SOM 6VI (SURGICAL OPERATING MICROSCOPE)
K926288 · Jedmed Instrument Co.
FSO · Microscope, Surgical, General & Plastic Surgery · 302d
Cleared Oct 12, 1993
ENDOPATH EP DISPOSABLE TROCAR
K922608 · Ethicon, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 497d
Cleared Oct 08, 1993
VISIDISC KITS, SPINESCOPE
K924720 · Laserscope
GEX · Powered Laser Surgical Instrument · 382d
Cleared Oct 05, 1993
DISTENTION INSTRUMENT, MODIFICATION
K934134 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 48d
Cleared Oct 01, 1993
PROCEDURE KITS
K933160 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 94d
Cleared Oct 01, 1993
SOLOSITE DERMAL WOUND GEL
K932263 · Smith & Nephew United, Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 164d
Cleared Sep 29, 1993
AUTO SUTURE ENDOSCOPIC INSTRUMENT CLAMP
K932885 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 107d
Cleared Sep 29, 1993
MONOJECT(R) MONOLETTOR SAFETY LANCET
K932785 · Sherwood Medical Co.
FMK · Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature · 112d
Cleared Sep 29, 1993
VALLEYLAB #E2751 & E2780R LAPAROSCOPIC HANDPIECE
K925647 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 324d
Cleared Sep 23, 1993
SURGICAL TROCAR AND CANNULA
K932995 · Applied Medical Resources
GCJ · Laparoscope, General & Plastic Surgery · 97d
Cleared Sep 23, 1993
ELECTROSURGICAL ELECTRODE
K932102 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 143d
Cleared Sep 23, 1993
SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM
K931978 · Sharplan Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 154d
Cleared Sep 23, 1993
POLYP SNARE NET W/MONOPOLAR CAUTERY
K926103 · United States Endoscopy Group, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 294d

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All categories 7713 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1108 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 222 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 106 FZP Clip, Implantable 101 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