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
13836 General & Plastic Surgery devices
5926–5950 of 13836
Cleared Mar 25, 2009
WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055
K083792 · Medshape Solutions
HWC · Screw, Fixation, Bone · 96d
Cleared Mar 20, 2009
STERIS CMAX XLT SURGICAL TABLE
K090136 · STERIS Corporation
FQO · Table, Operating-room, Ac-powered · 58d
Cleared Mar 20, 2009
MYOSCIENCE CRYO-TOUCH
K083493 · Myoscience, Inc.
GEH · Unit, Cryosurgical, Accessories · 115d
Cleared Mar 20, 2009
DERMATOLOGIC TREATMENT SYSTEM (DTS) G2
K082819 · Miramar Labs, Inc.
NEY · System, Ablation, Microwave And Accessories · 176d
Cleared Mar 20, 2009
SYNCHRO HP PLATFORM
K082039 · El.En Electronic Engineering Spa
GEX · Powered Laser Surgical Instrument · 245d
Cleared Mar 19, 2009
TAC-TITE (TM)
K090128 · Core Essence Orthopaedics, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 57d
Cleared Mar 19, 2009
AFFIRM CO2 AND AFFIRM CO2 HP
K081424 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 303d
Cleared Mar 18, 2009
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
K090547 · C.R. Bard, Inc.
NEU · Marker, Radiographic, Implantable · 16d
Cleared Mar 18, 2009
SECURIAN TISSUE REINFORCEMENT MATRIX
K083823 · Xylos Corporation
FTM · Mesh, Surgical · 86d
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

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All categories 13836 GEX Powered Laser Surgical Instrument 2356 GEI Electrosurgical, Cutting & Coagulation & Accessories 1844 GCJ Laparoscope, General & Plastic Surgery 1095 FRO Dressing, Wound, Drug 543 FTL Mesh, Surgical, Polymeric 307 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) 167 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