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
136d
Avg (2y)
1976
Since
7639 General & Plastic Surgery devices
3801–3825 of 7639
Cleared Mar 17, 2010
MODEL VISULAS 532S LASER WITH THE VITE OPTION
K100035 · Carl Zeiss Meditec, AG
GEX · Powered Laser Surgical Instrument · 70d
Cleared Mar 10, 2010
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK
K100506 · Teleflex Medical
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 16d
Cleared Mar 03, 2010
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
K093594 · Acclarent, Inc.
KAM · Cannula, Sinus · 104d
Cleared Feb 26, 2010
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841
K093203 · Medtronic, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 136d
Cleared Feb 24, 2010
VERSAPULSE MODEL P20 LASER SYSTEM
K100228 · Lumenis, Inc.
GEX · Powered Laser Surgical Instrument · 29d
Cleared Feb 17, 2010
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
K100218 · Coloplast A/S
FRO · Dressing, Wound, Drug · 22d
Cleared Feb 12, 2010
MODIFIED STRAIGHT FIRE LASER FIBER
K100078 · Boston Scientific Corp
GEX · Powered Laser Surgical Instrument · 31d
Cleared Jan 28, 2010
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
K092508 · Smith & Nephew, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 164d
Cleared Jan 26, 2010
ATRIUM C-QUR OVT MESH
K100076 · Atrium Medical Corp.
FTL · Mesh, Surgical, Polymeric · 14d
Cleared Jan 21, 2010
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
K093217 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 100d
Cleared Jan 15, 2010
ARTHROCARE COBLATOR IQ SYSTEM
K091674 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 220d
Cleared Jan 15, 2010
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
K091259 · Ethicon Endo-Surgery, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 261d
Cleared Jan 08, 2010
MATRIX RF APPLICATOR
K090025 · Syneron Medical, Ltd.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 368d
Cleared Jan 07, 2010
VARI-LASE ENDOVENOUS LASER CONSOLE
K093502 · Vascular Solutions, Inc.
GEX · Powered Laser Surgical Instrument · 56d
Cleared Jan 07, 2010
MEDLINE CURAD WOUND DRESSINGS
K093349 · Medline Industries, Inc.
FRO · Dressing, Wound, Drug · 72d
Cleared Dec 18, 2009
BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018
K092483 · C.R. Bard, Inc.
GDW · Staple, Implantable · 127d
Cleared Dec 16, 2009
INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
K090993 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 253d
Cleared Dec 11, 2009
ACCUMAX
K093691 · Boston Scientific Corp
GEX · Powered Laser Surgical Instrument · 11d
Cleared Dec 04, 2009
ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS
K093165 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 59d
Cleared Dec 03, 2009
SIROLASER ADVANCE
K092660 · Sirona Dental Systems GmbH
GEX · Powered Laser Surgical Instrument · 97d
Cleared Nov 27, 2009
ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
K091824 · Ethicon Endo-Surgery, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 161d
Cleared Nov 09, 2009
GREENLIGHT XPS LASER SYSTEM
K092735 · American Medical Systems, Inc.
GEX · Powered Laser Surgical Instrument · 66d
Cleared Nov 06, 2009
MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290
K092009 · Boston Scientific Corporation
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 123d
Cleared Nov 05, 2009
ALEXIS LAPAROSCOPIC SYSTEM
K093296 · Applied Medical Resources Corp.
KGW · Ring (wound Protector), Drape Retention, Internal · 15d
Cleared Oct 29, 2009
ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
K091290 · Ethicon Endo-Surgery, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 181d

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All categories 7639 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1106 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 214 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 101 FZP Clip, Implantable 98 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 93 LFL Instrument, Ultrasonic Surgical 85 KGN Wound Dressing With Animal-derived Material(s) 85 GEH Unit, Cryosurgical, Accessories 78