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

18201
Total
18157
Cleared
138d
Avg (2y)
1976
Since
4109 General & Plastic Surgery devices
3376–3400 of 4109
Cleared Feb 11, 2008
MENISCAL CINCH
K073149 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 95d
Cleared Nov 21, 2007
AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
K071406 · United States Surgical, A Division of Tyco Healthc
FZP · Clip, Implantable · 184d
Cleared Nov 09, 2007
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc.
FRO · Dressing, Wound, Drug · 77d
Cleared Oct 05, 2007
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072 · STERIS Corporation
FSY · Light, Surgical, Ceiling Mounted · 67d
Cleared Oct 05, 2007
REFLECTION, TANDEM UNIPOLAR
K071160 · Smith & Nephew, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 162d
Cleared Sep 28, 2007
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 78d
Cleared Sep 18, 2007
ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS
K072322 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 29d
Cleared Sep 04, 2007
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K071016 · DePuy Orthopaedics, Inc.
FTM · Mesh, Surgical · 147d
Cleared Aug 03, 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc.
FRO · Dressing, Wound, Drug · 220d
Cleared Aug 01, 2007
BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001
K070201 · C.R. Bard, Inc.
PHU · Intra-abdominal Pressure Monitoring Device · 191d
Cleared Jul 03, 2007
ARTHREX FIBERWIRE
K071622 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 19d
Cleared Jun 05, 2007
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
K071249 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 32d
Cleared Apr 24, 2007
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261
K070311 · Medtronic Vascular
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 82d
Cleared Apr 17, 2007
ULTRAPRO PLUG
K070224 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 83d
Cleared Apr 05, 2007
3M TEGADERM CHG DRESSING
K063458 · 3M Company
FRO · Dressing, Wound, Drug · 141d
Cleared Feb 22, 2007
560 HIGH DEFINITION CAMERA SYSTEM
K070266 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 24d
Cleared Feb 16, 2007
MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR
K062464 · KARL STORZ Endoscopy-America, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 176d
Cleared Dec 11, 2006
PROCEED VENTRAL PATCH
K061533 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 192d
Cleared Nov 21, 2006
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106
K063178 · C.R. Bard, Inc.
FTM · Mesh, Surgical · 33d
Cleared Nov 02, 2006
MEDLINE SURGICAL SPONGE SCANNER
K061316 · Medline Industries, Inc.
LWH · Counter, Sponge, Surgical · 175d
Cleared Nov 02, 2006
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
K061288 · United States Surgical, A Division of Tyco Healthc
FZP · Clip, Implantable · 177d
Cleared Oct 23, 2006
AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
K062850 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 28d
Cleared Oct 11, 2006
CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
K062727 · Medtronic Vascular
GCJ · Laparoscope, General & Plastic Surgery · 28d
Cleared Sep 01, 2006
AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
K062326 · United States Surgical, A Division of Tyco Healthc
GCJ · Laparoscope, General & Plastic Surgery · 23d
Cleared Aug 02, 2006
U-CLIP DEVICE, MODEL NC65
K062057 · Medtronic Vascular
FZP · Clip, Implantable · 13d

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All categories 4109 GEI Electrosurgical, Cutting & Coagulation & Accessories 539 GEX Powered Laser Surgical Instrument 498 GCJ Laparoscope, General & Plastic Surgery 334 FRO Dressing, Wound, Drug 163 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 118 GDW Staple, Implantable 107 NAY System, Surgical, Computer Controlled Instrument 99 FTL Mesh, Surgical, Polymeric 95 OMP Negative Pressure Wound Therapy Powered Suction Pump 93 KGN Wound Dressing With Animal-derived Material(s) 74 OAP Laser, Comb, Hair 72 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 71 GAM Suture, Absorbable, Synthetic, Polyglycolic Acid 62 GEH Unit, Cryosurgical, Accessories 62