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
14092 General & Plastic Surgery devices
9751–9775 of 14092
Cleared Sep 19, 1996
ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM
K962525 · Morwel Corp.
LFL · Instrument, Ultrasonic Surgical · 84d
Cleared Sep 19, 1996
ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE
K962692 · Zomed Intl.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 70d
Cleared Sep 18, 1996
ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY)
K963157 · Oratec Interventions, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 55d
Cleared Sep 16, 1996
POLYPROPYLENE MESH (VARIOUS SIZES)
K962971 · Davis & Geck, Inc.
FTL · Mesh, Surgical, Polymeric · 47d
Cleared Sep 13, 1996
SHEATH, ELECTROSURGICAL PENCIL
K963088 · Aspen Laboratories, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 36d
Cleared Sep 12, 1996
CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG
K962218 · Carrington Laboratories, Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 94d
Cleared Sep 12, 1996
DERMAPLEX HYDROGEL WOUND DRESSING
K962513 · Maxxim Medical
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 77d
Cleared Sep 11, 1996
PHOTODERM PL.
K960772 · Esc Medical Systems , Ltd.
GEX · Powered Laser Surgical Instrument · 198d
Cleared Sep 11, 1996
MEDLITE/755 ALEXANDRITE LASER SYSTEM
K961006 · Continuum Biomedical, Inc.
GEX · Powered Laser Surgical Instrument · 183d
Cleared Sep 11, 1996
HEAD MOUNTED DISPLAY
K961800 · Vista Medical Technologies, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 125d
Cleared Sep 11, 1996
AIRLIFT BALLOON RETRACTON SYSTEM
K962104 · Origin Medsystems, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 104d
Cleared Sep 11, 1996
ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
K962258 · Ethicon Endo-Surgery, Inc.
GAG · Stapler, Surgical · 91d
Cleared Sep 11, 1996
MODIFIED LEVEEN NEEDLE ELECTRODE
K962313 · Radiotherapeutics Corp.
JOS · Electrode, Electrosurgical · 86d
Cleared Sep 11, 1996
DIOMED 15, 30, 60 SURGICAL DIODE LASER
K962354 · Lifestream Int'L, Inc.
GEX · Powered Laser Surgical Instrument · 85d
Cleared Sep 11, 1996
BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)
K962425 · Radi Medical Systems AB
GAA · Needle, Aspiration And Injection, Disposable · 79d
Cleared Sep 06, 1996
DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
K962740 · Medi-Flex Hospital Products, Inc.
KMF · Bandage, Liquid · 53d
Cleared Sep 06, 1996
ACRYNOODLES ABSORBENT WOUND DRESSING
K962851 · Acrymed, Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 46d
Cleared Sep 06, 1996
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
K963134 · Igenics, Inc.
EFQ · Gauze/sponge, Internal · 25d
Cleared Sep 03, 1996
DURASIL (MODIFICATION)
K961410 · The S. F. Group, Inc.
MDA · Elastomer, Silicone, For Scar Management · 175d
Cleared Sep 03, 1996
SURESCAN
K962242 · Clinicon Corp.
GEX · Powered Laser Surgical Instrument · 84d
Cleared Sep 03, 1996
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K962401 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 74d
Cleared Sep 03, 1996
DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)
K962439 · Richard Hamer Assoc., Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 71d
Cleared Sep 03, 1996
SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
K962496 · Tissue Technologies, Inc.
FTL · Mesh, Surgical, Polymeric · 69d
Cleared Sep 03, 1996
UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE
K962935 · Unimed Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 36d
Cleared Aug 30, 1996
S-41 & S-41S VIDEO IMAGING SYSTEM
K962020 · Del Medical Systems Corp.
GCJ · Laparoscope, General & Plastic Surgery · 99d

Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.

Search all General & Plastic Surgery 510(k) devices

Filter by Product Code

All categories 14092 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