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
137d
Avg (2y)
1976
Since
7691 General & Plastic Surgery devices
4476–4500 of 7691
Cleared Feb 08, 2002
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
K013864 · Nidek, Inc.
GEX · Powered Laser Surgical Instrument · 79d
Cleared Feb 07, 2002
SMARTEPIL
K020107 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 27d
Cleared Feb 07, 2002
GELZONE
K013732 · Implantech Associates, Inc.
MDA · Elastomer, Silicone, For Scar Management · 90d
Cleared Feb 01, 2002
DYONICS ELECTROBLADE RESECTOR
K012314 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 193d
Cleared Jan 25, 2002
PERICSCOPE, MODEL # PERISC1
K013576 · Ethicon Endo-Surgery, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 88d
Cleared Jan 18, 2002
ARTHROCARE CONTROLLER, PATIENT CABLE, FOOT CONTROL, POWER CORD
K014222 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 23d
Cleared Jan 18, 2002
REPROCESSED ELECTROSURGICAL ELECTRODE
K012684 · Sterilmed, Inc.
JOS · Electrode, Electrosurgical · 157d
Cleared Jan 18, 2002
VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT
K012293 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 182d
Cleared Jan 17, 2002
SELF-DRILLING RADIOGRAPHIC MARKER
K014148 · Walter Lorenz Surgical, Inc.
NEU · Marker, Radiographic, Implantable · 30d
Cleared Jan 17, 2002
DILATING TIP OBTURATOR
K012884 · Applied Medical Resources Corp.
GCJ · Laparoscope, General & Plastic Surgery · 142d
Cleared Jan 10, 2002
7MM EXTENDED LENGTH ENDOSCOPE,DISSECTION TIPS, MODELS VH-1111, VH-1114
K014250 · Guidant Corp.
GCJ · Laparoscope, General & Plastic Surgery · 15d
Cleared Jan 10, 2002
INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY
K013416 · Intuitive Surgical, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 87d
Cleared Jan 10, 2002
LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107
K010033 · Richard Wolf Medical Instruments Corp.
GCJ · Laparoscope, General & Plastic Surgery · 371d
Cleared Jan 08, 2002
L-25 ABSORBABLE SURIGCAL SUTURE
K013671 · United States Surgical, A Division of Tyco Healthc
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 63d
Cleared Jan 08, 2002
VIABAHN ENDOPROSTHESIS
K013648 · W.L. Gore & Associates, Inc.
JCT · Prosthesis, Tracheal, Expandable · 64d
Cleared Dec 19, 2001
AUTO SUTURE SURGICAL STAPLES
K013860 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 28d
Cleared Dec 13, 2001
INDIGO OPTIMA LASER SYSTEM
K013493 · Ethicon Endo-Surgery, Inc.
GEX · Powered Laser Surgical Instrument · 52d
Cleared Dec 13, 2001
AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
K013242 · STERIS Corporation
FTD · Lamp, Surgical · 76d
Cleared Dec 06, 2001
REPROCESSED SOFT TISSUE ABLATORS
K012631 · Alliance Medical Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 115d
Cleared Dec 03, 2001
MICROMARK II TISSUE MARKER,MODEL C1535
K013413 · Ethicon Endo-Surgery, Inc.
NEU · Marker, Radiographic, Implantable · 49d
Cleared Dec 03, 2001
APPLIED ACCESS SEAL
K012968 · Applied Medical Resources Corp.
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared Dec 03, 2001
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500 · Mentor Corp.
LCJ · Tissue Expander And Accessories · 201d
Cleared Nov 27, 2001
RUSCH POLYFLEX STENT KIT
K013266 · Rusch Intl.
NYT · Prosthesis, Tracheal, Expandable, Polymeric · 57d
Cleared Nov 19, 2001
CYNOSURE PHOTOGENICA VL
K012806 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Nov 19, 2001
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE
K011322 · Dornier Medtech America, Inc.
GEX · Powered Laser Surgical Instrument · 202d

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All categories 7691 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1106 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 222 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