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
13848 General & Plastic Surgery devices
6101–6125 of 13848
Cleared Oct 15, 2008
VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-7-100-2
K082890 · Vnus Medical Technologies, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 15d
Cleared Oct 15, 2008
CARAPASTE ORAL WOUND DRESSING
K082856 · Mcgrath Pharmaceuticals, Inc.
OLR · Oral Wound Dressing · 16d
Cleared Oct 15, 2008
ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS
K082666 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 33d
Cleared Oct 15, 2008
CURATIVE980 DIODE LASER
K082445 · Oroscience, Inc.
GEX · Powered Laser Surgical Instrument · 51d
Cleared Oct 15, 2008
EVIS MD PLANTIUM BLUE
K082232 · Ageless Beauty Corporation
GEX · Powered Laser Surgical Instrument · 69d
Cleared Oct 14, 2008
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
K082828 · Suturtek Incorporated
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 19d
Cleared Oct 14, 2008
MRDH BANDAGE
K082703 · Marine Polymer Technologies, Inc.
KMF · Bandage, Liquid · 28d
Cleared Oct 09, 2008
UltraClot, UltraClot OTC
K082601 · Emergency Medical Devices, LLC
QSY · Hemostatic Wound Dressing Without Thrombin Or Other Biologics · 31d
Cleared Oct 09, 2008
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
K082330 · Primary Care Solutions, Inc.
FRO · Dressing, Wound, Drug · 56d
Cleared Oct 09, 2008
NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K080275 · Iasis Medical, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 251d
Cleared Oct 08, 2008
EXSUDEX WOUND DRAINAGE PUMP
K082311 · The Medical Company
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 56d
Cleared Oct 08, 2008
EVIS MD PLATINUM RED LIGHT THERAPY
K082247 · Ageless Beauty Corporation
GEX · Powered Laser Surgical Instrument · 61d
Cleared Oct 08, 2008
HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B
K082202 · Barrx Medical, Incorporated
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 64d
Cleared Oct 08, 2008
LTM WOUND DRESSING
K082103 · Lifecell Corp.
KGN · Wound Dressing With Animal-derived Material(s) · 75d
Cleared Oct 08, 2008
POWERLIPO LASER SYSTEM
K082096 · Lutronic Corporation
GEX · Powered Laser Surgical Instrument · 76d
Cleared Oct 07, 2008
BARD 3DMAX MESH
K081010 · Davol Inc., Sub. C. R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 181d
Cleared Oct 02, 2008
BOVIE ICON GENERAL PURPOSE RF GENERATOR
K082109 · Bovie Medical
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 69d
Cleared Oct 02, 2008
STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)
K081995 · Stryker Endoscopy
GCJ · Laparoscope, General & Plastic Surgery · 80d
Cleared Oct 01, 2008
CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830
K073022 · Clareblend, Inc.
GEX · Powered Laser Surgical Instrument · 341d
Cleared Oct 01, 2008
LUMAPROBE
K073000 · Clareblend, Inc.
GEX · Powered Laser Surgical Instrument · 343d
Cleared Sep 30, 2008
COLLIEVA
K081782 · Innocoll Pharmaceuticals
KGN · Wound Dressing With Animal-derived Material(s) · 99d
Cleared Sep 29, 2008
VENTRIO HERNIA PATCH
K081777 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 98d
Cleared Sep 29, 2008
AED BIPOLAR FORCEPS, MODEL 13-1646
K081553 · National Advanced Endoscopy Devices, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 118d
Cleared Sep 26, 2008
SMOOTHKIT+
K082004 · Osyris
GEX · Powered Laser Surgical Instrument · 74d
Cleared Sep 25, 2008
AED MONOPOLAR LAP ACCESSORIES
K081503 · National Advanced Endoscopy Devices, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 119d

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All categories 13848 GEX Powered Laser Surgical Instrument 2357 GEI Electrosurgical, Cutting & Coagulation & Accessories 1846 GCJ Laparoscope, General & Plastic Surgery 1095 FRO Dressing, Wound, Drug 546 FTL Mesh, Surgical, Polymeric 309 GDW Staple, Implantable 252 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 207 KGN Wound Dressing With Animal-derived Material(s) 168 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 154 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 153