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
7632 General & Plastic Surgery devices
3426–3450 of 7632
Cleared Apr 29, 2015
IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps
K150837 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 30d
Cleared Apr 29, 2015
ULTRA Telescopes
K150633 · Olympus Winter & Ibe GmbH
GCJ · Laparoscope, General & Plastic Surgery · 49d
Cleared Apr 29, 2015
RENASYS
K142979 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 196d
Cleared Apr 16, 2015
Voyant Fine Fusion Device
K143536 · Applied Medical Resources
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 122d
Cleared Apr 08, 2015
Exilite
K150051 · BTL Industries, Inc.
ONF · Powered Light Based Non-laser Surgical Instrument With Thermal Effect · 86d
Cleared Apr 03, 2015
Valleylab LS10 Generator
K143654 · Covidien, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 101d
Cleared Apr 02, 2015
Force Fiber OrthoTape suture
K150438 · Teleflexmedical, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 42d
Cleared Apr 02, 2015
IS4000 8mm Harmonic ACE Curved Shears
K143132 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 153d
Cleared Mar 30, 2015
GORE SEAMGUARD Reinforcement
K150551 · W.L. Gore & Associates, Inc.
OXC · Mesh, Surgical, Absorbable, Staple Line Reinforcement · 26d
Cleared Mar 27, 2015
Voyant Open Sealer-Divider Device
K143517 · Applied Medical Resources
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 105d
Cleared Mar 26, 2015
PLIASURE Polyglycolide Synthetic Absorbable Suture
K142822 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 177d
Cleared Mar 25, 2015
Modified ONFLEX Mesh
K142706 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 184d
Cleared Mar 23, 2015
Stryker CMF MEDPOR Customized Implant
K143173 · Stryker
FWP · Prosthesis, Chin, Internal · 139d
Cleared Mar 20, 2015
ONFLEX Mesh
K142711 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 179d
Cleared Mar 18, 2015
COOK HOLMIUM LASER FIBER
K133788 · Cook Incorporated
GEX · Powered Laser Surgical Instrument · 461d
Cleared Mar 13, 2015
Progrip Laparoscopic Self-Fixating Mesh
K143386 · Sofradim Production
FTL · Mesh, Surgical, Polymeric · 107d
Cleared Mar 12, 2015
Lapro-Clip Auto Suture Reusable Long Clip Applier
K143598 · Covidien, LLC
FZP · Clip, Implantable · 84d
Cleared Mar 12, 2015
OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners
K142873 · C.R. Bard, Inc.
GDW · Staple, Implantable · 162d
Cleared Mar 09, 2015
CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners
K142808 · C.R. Bard, Inc.
GDW · Staple, Implantable · 161d
Cleared Mar 06, 2015
XP300
K143109 · BTL Industries, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 128d
Cleared Mar 05, 2015
Entriport
K142464 · Conmed Corporation
GCJ · Laparoscope, General & Plastic Surgery · 184d
Cleared Feb 23, 2015
Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
K143260 · Sterilmed, Inc.
NUJ · Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed · 102d
Cleared Feb 23, 2015
Picosure Workstation
K143105 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 117d
Cleared Feb 18, 2015
E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL
K141587 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 250d
Cleared Feb 04, 2015
Laparoscopic Handles with peek Insulation
K150127 · Stryker Endoscopy
GCJ · Laparoscope, General & Plastic Surgery · 15d

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All categories 7632 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1105 GCJ Laparoscope, General & Plastic Surgery 681 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