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
13976 General & Plastic Surgery devices
7676–7700 of 13976
Cleared Jan 27, 2004
AC APPLICATOR, AURORA AC
K032514 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 166d
Cleared Jan 21, 2004
TRISTAR AESTHETIC WORKSTATION LASER
K033176 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 112d
Cleared Jan 16, 2004
CANDELA CBEAM PULSE DYE LASER SYSTEM
K033331 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 92d
Cleared Jan 16, 2004
CANDELA VBEAM PULSE DYE LASER SYSTEM
K033461 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 78d
Cleared Jan 15, 2004
UGYTEX MESH
K033376 · Sofradim Production
FTL · Mesh, Surgical, Polymeric · 85d
Cleared Jan 15, 2004
FORCE FIBER
K033654 · Teleflex Medical
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 55d
Cleared Jan 14, 2004
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239
K032245 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 176d
Cleared Dec 31, 2003
GORE BIOABSORBABLE MESH
K033671 · W.L. Gore & Associates, Inc.
OWT · Mesh, Surgical, Absorbable, Abdominal Hernia · 37d
Cleared Dec 18, 2003
REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS
K032973 · Vanguard Medical Concepts, Inc.
GDW · Staple, Implantable · 85d
Cleared Dec 18, 2003
AMI REPROCESSED MULTIPLE CLIP APPLIERS
K032980 · Vanguard Medical Concepts, Inc.
FZP · Clip, Implantable · 85d
Cleared Dec 18, 2003
COAPT ENDOTINE CHIN 3.5 DEVICE
K033524 · Coapt Systems, Inc.
HWC · Screw, Fixation, Bone · 41d
Cleared Dec 18, 2003
VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE
K033709 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 22d
Cleared Dec 18, 2003
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
K033746 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 17d
Cleared Dec 15, 2003
TRIDENT RESECTION ABLATOR
K033748 · Linvatec Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d
Cleared Dec 10, 2003
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269 · Ethicon Endo-Surgery, Inc.
OCW · Endoscopic Tissue Approximation Device · 62d
Cleared Dec 10, 2003
MODIFICATION TO AURORA DS
K033586 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 27d
Cleared Dec 09, 2003
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K032690 · Misonix, Inc.
LFL · Instrument, Ultrasonic Surgical · 98d
Cleared Dec 03, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K030834 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 261d
Cleared Dec 02, 2003
STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
K032901 · Stryker Endoscopy
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 76d
Cleared Dec 01, 2003
POLARIS WR
K031671 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 186d
Cleared Dec 01, 2003
AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
K032696 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 90d
Cleared Nov 28, 2003
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K032865 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 77d
Cleared Nov 28, 2003
MALIS IRRIGATION MODULE 1000
K033499 · Valley Forge Scientific Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 23d
Cleared Nov 28, 2003
ARTHROCARE ARTHROWANDS
K033584 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 15d
Cleared Nov 26, 2003
OPTIMESH
K014200 · Spineology, Inc.
EZX · Mesh, Surgical, Metal · 705d

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All categories 13976 GEX Powered Laser Surgical Instrument 2370 GEI Electrosurgical, Cutting & Coagulation & Accessories 1864 GCJ Laparoscope, General & Plastic Surgery 1111 FRO Dressing, Wound, Drug 565 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 256 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 209 KGN Wound Dressing With Animal-derived Material(s) 169 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 159 EFQ Gauze/sponge, Internal 157 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 156 KMF Bandage, Liquid 155