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

18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
13720 General & Plastic Surgery devices
4126–4150 of 13720
Cleared Oct 20, 2015
Ultraviolet Sun Tanning Lamp
K151674 · G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh
LEJ · Booth, Sun Tan · 120d
Cleared Oct 19, 2015
Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel
K150156 · Ranfac, Corp.
MUU · System, Suction, Lipoplasty · 269d
Cleared Oct 16, 2015
Bladeless Optical Obturators
K152663 · Intuitive Surgical, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 29d
Cleared Oct 15, 2015
MONTAGE Settable, Resorbable Hemostatic Bone Putty
K152005 · Orthocon, Inc.
MTJ · Wax, Bone · 87d
Cleared Oct 15, 2015
LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip
K150835 · Covidien
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 199d
Cleared Oct 14, 2015
truFreeze System
K152668 · CSA Medical, Inc.
GEH · Unit, Cryosurgical, Accessories · 27d
Cleared Oct 14, 2015
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
K150717 · M/s. Meril Endo Surgery Private Limited.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 209d
Cleared Oct 09, 2015
Auto Suture Locking Trocar
K152565 · Covidien
GCJ · Laparoscope, General & Plastic Surgery · 30d
Cleared Oct 09, 2015
CLICKLINE Scissor Insert for Single Use
K151044 · KARL STORZ Endoscopy-America, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 172d
Cleared Oct 08, 2015
Medilas H RFID Laser Fibers
K152591 · Dornier Medtech America, Inc.
GEX · Powered Laser Surgical Instrument · 28d
Cleared Oct 08, 2015
WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
K134036 · Loktal Medical Electronics Ind. Com. Ltda- Epp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 646d
Cleared Oct 07, 2015
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large
K151261 · Medela AG
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 148d
Cleared Oct 05, 2015
Ultraviolet Sunlamps
K151841 · Wolff System Technology Corp.
LEJ · Booth, Sun Tan · 91d
Cleared Oct 01, 2015
SIS Inguinal Hernia Repair Graft
K142887 · Cook Biotech Incorprated
FTM · Mesh, Surgical · 364d
Cleared Sep 23, 2015
Stretta Catheter
K152317 · Mederi Therapeutics, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 37d
Cleared Sep 23, 2015
Solea
K151306 · Convergent Dental, Inc.
GEX · Powered Laser Surgical Instrument · 128d
Cleared Sep 22, 2015
ZELTIQ CoolSculpting System
K151179 · Zeltiq Aesthetics, Inc.
OOK · Dermal Cooling Pack/vacuum/massager · 141d
Cleared Sep 22, 2015
Universal Light Handle Cover, Light Handle Cover
K150532 · Key Surgical, Inc.
FTA · Light, Surgical, Accessories · 204d
Cleared Sep 18, 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K143743 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 261d
Cleared Sep 17, 2015
New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.
K152031 · New Deantronics Taiwan , Ltd.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 57d
Cleared Sep 17, 2015
KSEA CMOS Camera System (C-cam)
K143640 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 269d
Cleared Sep 16, 2015
ELUMI 810 + 980 Soft Tissue Laser
K152032 · Azena Medical, LLC
GEX · Powered Laser Surgical Instrument · 56d
Cleared Sep 16, 2015
Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
K151400 · Jk Holding GmbH
LEJ · Booth, Sun Tan · 113d
Cleared Sep 16, 2015
XP3000
K150720 · BTL Industries, Inc.
PBX · Massager, Vacuum, Radio Frequency Induced Heat · 181d
Cleared Sep 15, 2015
CO2RE System
K151655 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 89d

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All categories 13720 GEX Powered Laser Surgical Instrument 2342 GEI Electrosurgical, Cutting & Coagulation & Accessories 1833 GCJ Laparoscope, General & Plastic Surgery 1083 FRO Dressing, Wound, Drug 529 FTL Mesh, Surgical, Polymeric 305 GDW Staple, Implantable 249 GEH Unit, Cryosurgical, Accessories 208 OMP Negative Pressure Wound Therapy Powered Suction Pump 205 KGN Wound Dressing With Animal-derived Material(s) 163 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 158 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 154 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 147