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

18256
Total
18211
Cleared
136d
Avg (2y)
1976
Since
7655 General & Plastic Surgery devices
4201–4225 of 7655
Cleared Feb 18, 2005
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
K050187 · Sofradim Production
FTL · Mesh, Surgical, Polymeric · 22d
Cleared Feb 18, 2005
D-STAT RADIAL HEMOSTATIC BAND
K050133 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 28d
Cleared Feb 09, 2005
BONE SOURCE HAC RAPID SETTING CEMENT
K043334 · Stryker Instruments
GXP · Methyl Methacrylate For Cranioplasty · 68d
Cleared Feb 09, 2005
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
K043251 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 78d
Cleared Feb 01, 2005
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
K050102 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d
Cleared Jan 25, 2005
INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179
K050005 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 22d
Cleared Jan 25, 2005
V.A.C. GRANUFOAM SILVER DRESSING
K041642 · Kinetic Concepts, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 222d
Cleared Jan 12, 2005
CYNERGY LASER
K043429 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 30d
Cleared Dec 22, 2004
GORE POLYPROPYLENE HERNIA MESH
K043081 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 44d
Cleared Dec 22, 2004
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K043056 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 47d
Cleared Dec 21, 2004
CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884
K043291 · Medtronic Vascular
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 22d
Cleared Dec 21, 2004
SERFAS ENERGY SYSTEM
K041810 · Stryker Endoscopy
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 168d
Cleared Dec 15, 2004
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000
K043153 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 30d
Cleared Dec 14, 2004
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
K042785 · Nidek, Inc.
GEX · Powered Laser Surgical Instrument · 69d
Cleared Dec 10, 2004
ARTHREX SUTURE GRAFTING KIT
K041553 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 184d
Cleared Dec 01, 2004
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
K042777 · Ethicon Endo-Surgery, Inc.
LFL · Instrument, Ultrasonic Surgical · 56d
Cleared Nov 22, 2004
CANDELA SMOOTHBEAM LASER SYSTEM
K041242 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 195d
Cleared Nov 19, 2004
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
K042897 · Ethicon Endo-Surgery, Inc.
GAL · Suture, Absorbable, Natural · 30d
Cleared Nov 17, 2004
OMNIPULSE MINI, MODEL 2120
K043012 · Trimedyne, Inc.
GEX · Powered Laser Surgical Instrument · 15d
Cleared Nov 12, 2004
INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
K042855 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 28d
Cleared Nov 08, 2004
MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
K042211 · Surgical Laser Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 84d
Cleared Nov 08, 2004
POLARIS DS/COMET
K041959 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 110d
Cleared Nov 02, 2004
3M TEGADERM SILVER
K040890 · 3M Company
FRO · Dressing, Wound, Drug · 223d
Cleared Oct 26, 2004
NUVASIVE MAXCESS LIGHT GUIDE
K042034 · Nuvasive, Inc.
FST · Light, Surgical, Fiberoptic · 89d
Cleared Oct 19, 2004
AURORA DS
K041969 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 89d

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All categories 7655 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1106 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 216 FTL Mesh, Surgical, Polymeric 186 GDW Staple, Implantable 159 NAY System, Surgical, Computer Controlled Instrument 158 OHT Light Based Over-the-counter Hair Removal 142 OHS Light Based Over The Counter Wrinkle Reduction 120 OMP Negative Pressure Wound Therapy Powered Suction Pump 101 FZP Clip, Implantable 100 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 93 LFL Instrument, Ultrasonic Surgical 85 KGN Wound Dressing With Animal-derived Material(s) 85 GEH Unit, Cryosurgical, Accessories 78