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
13852 General & Plastic Surgery devices
5951–5975 of 13852
Cleared Mar 17, 2009
ELITE MPX LASER SYSTEM WITH XPL HANDPIECE
K090235 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 43d
Cleared Mar 17, 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141 · B.Braun Medical, Inc.
FRO · Dressing, Wound, Drug · 55d
Cleared Mar 17, 2009
SMOOTHLIPO
K083478 · Eleme Medical, Inc.
GEX · Powered Laser Surgical Instrument · 113d
Cleared Mar 13, 2009
PICASSO LASER SYSTEM
K083142 · Amd Lasers, LLC
GEX · Powered Laser Surgical Instrument · 141d
Cleared Mar 13, 2009
STONE GRASPING BASKET, MODEL PD-T1 2115
K082735 · Sialo Technology, Ltd.
GCJ · Laparoscope, General & Plastic Surgery · 176d
Cleared Mar 11, 2009
SOFTSEAL-STF
K090100 · Chitogen, Inc.
QSY · Hemostatic Wound Dressing Without Thrombin Or Other Biologics · 55d
Cleared Mar 11, 2009
AERO DV TRACHEOBRONCHIAL STENT SYSTEM
K083625 · Alveolus, Inc.
JCT · Prosthesis, Tracheal, Expandable · 93d
Cleared Mar 06, 2009
ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE
K090084 · Merit Medical Systems, Inc.
GEX · Powered Laser Surgical Instrument · 53d
Cleared Mar 06, 2009
TC ENDO PORT
K083218 · Transcardiac Therapeutics, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 126d
Cleared Mar 05, 2009
BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1
K090501 · Biopsy Sciences, LLC
NEU · Marker, Radiographic, Implantable · 8d
Cleared Mar 04, 2009
ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES
K090281 · Accutech Medical Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 27d
Cleared Mar 04, 2009
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
K083357 · Kci USA, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 111d
Cleared Mar 02, 2009
ATRICURE CRYO1 CRYO-ABLATION PROBE
K082074 · AtriCure, Inc.
GEH · Unit, Cryosurgical, Accessories · 222d
Cleared Feb 27, 2009
ATMOS C361/C451 SUCTION PUMP
K090445 · Atmos, Inc.
BTA · Pump, Portable, Aspiration (manual Or Powered) · 7d
Cleared Feb 27, 2009
ERBIUM FRACTIONAL HANDPIECE
K083900 · Palomar Medical Products, Inc.
GEX · Powered Laser Surgical Instrument · 60d
Cleared Feb 27, 2009
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
K082682 · Cook Biotech, Inc.
FTM · Mesh, Surgical · 165d
Cleared Feb 26, 2009
SILVER ALGINATE 11 WOUND DRESSING
K090453 · Advanced Medical Solutions Limited
FRO · Dressing, Wound, Drug · 3d
Cleared Feb 26, 2009
LH-75T PHOTOTHERAPY SYSTEM
K090097 · Lerner Medical Devices, Inc.
FTC · Light, Ultraviolet, Dermatological · 42d
Cleared Feb 26, 2009
ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
K083103 · Acrymed, Inc.
FRO · Dressing, Wound, Drug · 129d
Cleared Feb 26, 2009
COPA AMD
K082296 · Covidien Lp, Formerly Registered AS Tyco Healthcar
FRO · Dressing, Wound, Drug · 198d
Cleared Feb 25, 2009
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 103d
Cleared Feb 25, 2009
EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-
K083281 · Linvatec Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 110d
Not Cleared Feb 25, 2009
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
DEN070002 · Quick-Med Technologies, Inc.
NYS · Wound Dressing With Poly(diallyl Dimethyl Ammonium Chloride)(pdadmac) · 657d
Cleared Feb 23, 2009
CHROMOPHARE E 668
K090378 · Berchtold GmbH & Co. KG
FSY · Light, Surgical, Ceiling Mounted · 6d
Cleared Feb 23, 2009
GLUSEAL 90, MODEL GLU9010
K083752 · Glustitch, Inc.
KMF · Bandage, Liquid · 68d

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All categories 13852 GEX Powered Laser Surgical Instrument 2357 GEI Electrosurgical, Cutting & Coagulation & Accessories 1846 GCJ Laparoscope, General & Plastic Surgery 1095 FRO Dressing, Wound, Drug 548 FTL Mesh, Surgical, Polymeric 309 GDW Staple, Implantable 252 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 207 KGN Wound Dressing With Animal-derived Material(s) 168 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 153