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
4106 General & Plastic Surgery devices
3176–3200 of 4106
Cleared Jan 18, 2018
Stryker AIM Light Source and SafeLight cable
K173866 · Stryker
OWN · Confocal Optical Imaging · 29d
Cleared Jan 18, 2018
Lumilisse IPL Hair Remover
K172791 · Conair Corporation
OHT · Light Based Over-the-counter Hair Removal · 125d
Cleared Jan 17, 2018
ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
K173582 · Thermigen, L.L.C
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 58d
Cleared Jan 12, 2018
Aleo BME Liquid Bandage
K171148 · Aleo Bme, Inc.
KMF · Bandage, Liquid · 268d
Cleared Jan 09, 2018
reVive Perioral
K172662 · Led Technologies, Inc.
OHS · Light Based Over The Counter Wrinkle Reduction · 126d
Cleared Jan 09, 2018
Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
K172193 · Alma Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 172d
Cleared Jan 09, 2018
Theradome LH80 PRO
K171775 · Theradome, Inc.
OAP · Laser, Comb, Hair · 209d
Cleared Jan 08, 2018
Thermage CPT System and Accessories
K173759 · Solta Medical
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 28d
Cleared Jan 05, 2018
Hair Up
K172968 · Y & J Bio Co., Ltd.
OAP · Laser, Comb, Hair · 101d
Cleared Dec 05, 2017
SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
K172618 · Olympus Medical Systems Corp.
GCJ · Laparoscope, General & Plastic Surgery · 96d
Cleared Nov 02, 2017
Valleylab FX8 Electrosurgical Platform
K172757 · Covidien, LLC
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 50d
Cleared Nov 01, 2017
Surgical Stainless Steel Suture, Stainless Steel Suture
K170767 · Ethicon, Inc.
GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 232d
Cleared Oct 26, 2017
Rhapsody H-30 Holmium Laser System
K172325 · Cook Incorporated
GEX · Powered Laser Surgical Instrument · 86d
Cleared Oct 23, 2017
gi-4000 Electrosurgical Generator
K172805 · United States Endoscopy Group, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 35d
Cleared Oct 23, 2017
Monosyn Quick Synthetic Absorbable Surgical Suture
K171001 · Aesculap, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 202d
Cleared Oct 18, 2017
ANCHOR Tissue Retrieval System
K172940 · Conmed Corporation
GCJ · Laparoscope, General & Plastic Surgery · 22d
Cleared Oct 05, 2017
PROLENE Soft Polypropylene Mesh
K172089 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 86d
Cleared Oct 04, 2017
Ultrasonic Generator
K172691 · Olympus Medical Systems Corp.
LFL · Instrument, Ultrasonic Surgical · 28d
Cleared Oct 04, 2017
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal
K172671 · Conmed Corporation
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d
Cleared Sep 26, 2017
SculpSure
K171992 · Cynosure, Inc.
PKT · Laser For Disruption Of Adipocyte Cells For Aesthetic Use · 85d
Cleared Sep 22, 2017
TempSure
K171262 · Cynosure, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 144d
Cleared Sep 21, 2017
IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
K170879 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 181d
Cleared Sep 21, 2017
da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
K170641 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 203d
Cleared Sep 19, 2017
da Vinci Xi Surgical System
K171632 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 109d
Cleared Sep 12, 2017
da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories
K170875 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 172d

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All categories 4106 GEI Electrosurgical, Cutting & Coagulation & Accessories 539 GEX Powered Laser Surgical Instrument 497 GCJ Laparoscope, General & Plastic Surgery 333 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