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
4108 General & Plastic Surgery devices
3226–3250 of 4108
Cleared Apr 21, 2017
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories
K170865 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 29d
Cleared Apr 11, 2017
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
K163698 · C.R. Bard, Inc.
GDW · Staple, Implantable · 103d
Cleared Mar 11, 2017
PROLENE Soft Polypropylene Mesh
K163152 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 121d
Cleared Mar 10, 2017
EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads
K170508 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 17d
Cleared Mar 08, 2017
VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar
K163654 · Covidien, LLC
GCJ · Laparoscope, General & Plastic Surgery · 75d
Cleared Mar 02, 2017
Signia Four-Bay Smart Charger (to be used with Signia Stapler)
K170348 · Covidien
GDW · Staple, Implantable · 27d
Cleared Feb 17, 2017
ExpressBraid Graft Manipulation
K163651 · Biomet Manufacturing Corp
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 56d
Cleared Feb 16, 2017
Valleylab FT10 Electrosurgical Platform
K170170 · Covidien, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 28d
Cleared Feb 10, 2017
GORE BIO-A Tissue Reinforcement
K163217 · W.L. Gore & Associates, Inc.
OXF · Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery · 86d
Cleared Feb 06, 2017
EndoWrist Suction Irrigator
K162973 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 104d
Cleared Jan 26, 2017
KARL STORZ ICG Imaging System
K162882 · KARL STORZ Endoscopy-America, Inc.
OWN · Confocal Optical Imaging · 104d
Cleared Jan 24, 2017
Barrx Anorectal RFA Wand
K162802 · Covidien, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 111d
Cleared Jan 19, 2017
da Vinci Xi Surgical System
K161178 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 268d
Cleared Sep 29, 2016
Phasix Mesh
K161424 · C.R. Bard, Inc.
OOD · Surgical Film · 129d
Cleared Sep 29, 2016
RENASYS GO
K152163 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 423d
Cleared Sep 09, 2016
Arthrex Synergy RF System
K161581 · Arthrex, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 93d
Cleared Aug 31, 2016
RENASYS-G Gauze Dressing Kits with Soft Port
K162129 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 30d
Cleared Jul 12, 2016
E-Pack Procedure Kit
K161726 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 20d
Cleared May 31, 2016
CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners
K160900 · C.R. Bard, Inc.
GDW · Staple, Implantable · 60d
Cleared May 31, 2016
KARL STORZ Endoscopic ICG Imaging System
K152583 · KARL STORZ Endoscopy-America, Inc.
OWN · Confocal Optical Imaging · 264d
Cleared May 26, 2016
AdTec
K160393 · Aesculap, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 105d
Cleared May 19, 2016
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
K152842 · Boston Scientific Corporation
JCT · Prosthesis, Tracheal, Expandable · 233d
Cleared May 13, 2016
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
K153236 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 186d
Cleared Feb 17, 2016
Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture
K151165 · Aesculap, Inc.
GAR · Suture, Nonabsorbable, Synthetic, Polyamide · 292d
Cleared Feb 12, 2016
Arthrex Synergy UHD4 System
K153218 · Arthrex, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 99d

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All categories 4108 GEI Electrosurgical, Cutting & Coagulation & Accessories 539 GEX Powered Laser Surgical Instrument 497 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