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
13944 General & Plastic Surgery devices
7201–7225 of 13944
Cleared Oct 25, 2005
ATRICURE TRANSPOLAR SYSTEM
K052893 · AtriCure, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 11d
Cleared Oct 25, 2005
AQUAMANTYS PUMP GENERATOR SYSTEM
K052859 · Tissuelink Medical, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d
Cleared Oct 25, 2005
GYRUS PLASMACISION AND PLASMABLEND ELECTRODES
K050460 · Gyrus Medical, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 244d
Cleared Oct 24, 2005
ALUMA SKIN RENEWAL SYSTEM
K051214 · Lumenis, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 165d
Cleared Oct 21, 2005
ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000
K052857 · Senorx, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 10d
Cleared Oct 21, 2005
SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE
K052652 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 25d
Cleared Oct 21, 2005
DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
K052286 · The Catheter Exchange, Inc.
GBX · Catheter, Irrigation · 60d
Cleared Oct 21, 2005
ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185
K052104 · Conmed Corporation
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 79d
Cleared Oct 20, 2005
THERMAGE THERMACOOL SKIN MARKETING
K052778 · Thermage, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 17d
Cleared Oct 20, 2005
MEDLINE IODOFORM PACKING STRIPS
K052720 · Medline Industries, Inc.
FRO · Dressing, Wound, Drug · 21d
Cleared Oct 20, 2005
AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600
K052203 · Kirwan Surgical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 69d
Cleared Oct 20, 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 73d
Cleared Oct 17, 2005
BURANE
K052806 · Wavelight Laser Technologie AG
GEX · Powered Laser Surgical Instrument · 13d
Cleared Oct 17, 2005
NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
K052740 · Conmed Integrated Systems (Cmis)
GCJ · Laparoscope, General & Plastic Surgery · 17d
Cleared Oct 17, 2005
MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT)
K052660 · The Richmond Light Co.
FTC · Light, Ultraviolet, Dermatological · 20d
Cleared Oct 17, 2005
ARTELON SURGICAL SUTURE
K052482 · Artimplant AB
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 38d
Cleared Oct 17, 2005
CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189
K052449 · Codman & Shurtleff, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 41d
Cleared Oct 17, 2005
BIODERM SCIENCES WOUND CREAM
K042352 · Bioderm Sciences, Inc.
FRO · Dressing, Wound, Drug · 413d
Cleared Oct 17, 2005
NEWGEL AND NEWGEL PLUS E
K041704 · Newmedical Technology, Inc.
MDA · Elastomer, Silicone, For Scar Management · 481d
Cleared Oct 11, 2005
AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE
K052528 · Ceremed , Inc.
MTJ · Wax, Bone · 27d
Cleared Oct 11, 2005
ATRILAZE MALLEABLE ABLATION PROBE
K052495 · Medical Cv, Inc.
GEX · Powered Laser Surgical Instrument · 29d
Cleared Oct 11, 2005
SPECTRAQUATTRO PULSED LIGHT SYSTEM
K052336 · Amjet Distribution, LLC
GEX · Powered Laser Surgical Instrument · 46d
Cleared Oct 11, 2005
VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15)
K052003 · Vnus Medical Technologies, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 78d
Cleared Oct 07, 2005
SORING GMBH SONOCA LIPO
K052183 · Soring GmbH Medizintechnik
QPB · System, Suction, Lipoplasty For Removal · 58d
Cleared Oct 07, 2005
INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
K051950 · Ethicon Endo-Surgery, Inc.
MND · Ligator, Esophageal · 81d

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 13944 GEX Powered Laser Surgical Instrument 2365 GEI Electrosurgical, Cutting & Coagulation & Accessories 1859 GCJ Laparoscope, General & Plastic Surgery 1105 FRO Dressing, Wound, Drug 562 FTL Mesh, Surgical, Polymeric 315 GDW Staple, Implantable 255 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 209 KGN Wound Dressing With Animal-derived Material(s) 169 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 159 EFQ Gauze/sponge, Internal 157 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 155 KMF Bandage, Liquid 155