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
7697 General & Plastic Surgery devices
4501–4525 of 7697
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
Cleared Nov 16, 2001
INTUITIVE SURGICAL BIPOLAR FORCEPS
K012833 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 85d
Cleared Nov 16, 2001
CYNOSURE PHOTOGENICA ER
K012790 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 88d
Cleared Nov 15, 2001
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
K013463 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 28d
Cleared Nov 14, 2001
VISULAS 532S
K013402 · Carl Zeiss, Inc.
GEX · Powered Laser Surgical Instrument · 30d
Cleared Nov 14, 2001
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
K012738 · Depuyacromed
GEY · Motor, Surgical Instrument, Ac-powered · 90d
Cleared Nov 08, 2001
REPROCESSED LASER PROBE
K012682 · Sterilmed, Inc.
GEX · Powered Laser Surgical Instrument · 86d
Cleared Nov 08, 2001
REPROCESSED RF ARTHROSCOPY PROBES
K012679 · Sterilmed, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 86d
Cleared Nov 07, 2001
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS
K012700 · Vanguard Medical Concepts, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 85d
Cleared Nov 07, 2001
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
K012603 · Alliance Medical Corp.
NUJ · Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed · 86d
Cleared Nov 07, 2001
REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
K012598 · Sterilmed, Inc.
NUJ · Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed · 89d
Cleared Nov 07, 2001
REPROCESSED HARMONIC
K012571 · Sterilmed, Inc.
NLQ · Single-use Reprocessed Ultrasonic Surgical Instruments · 90d
Cleared Nov 01, 2001
KSEA SIALOENDOSCOPES AND ACCESSORIES
K012527 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 87d
Cleared Oct 30, 2001
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
K012695 · Vanguard Medical Concepts, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 77d
Cleared Oct 26, 2001
MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
K013348 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 17d
Cleared Oct 25, 2001
ARTHROCARE ELECTROSURGERY WANDS
K012519 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 80d
Cleared Oct 24, 2001
CONFORM SHEETING, MODEL IGEL
K012419 · Implantech Associates, Inc.
MDA · Elastomer, Silicone, For Scar Management · 86d
Cleared Oct 22, 2001
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
K012625 · Alliance Medical Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 70d
Cleared Oct 19, 2001
POWERPRO BATTERY SYSTEM
K012320 · Linvatec Corp.
HAB · Saw, Powered, And Accessories · 88d
Cleared Oct 12, 2001
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
K004005 · Mentor Corp.
QPB · System, Suction, Lipoplasty For Removal · 290d
Cleared Oct 11, 2001
CANDELA CLEARBEAM PULSED DYE LASER
K013043 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 31d
Cleared Oct 04, 2001
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
K012923 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 34d
Cleared Oct 03, 2001
BIPOLAR IRRIGATION FORCEPS
K012986 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 27d
Cleared Oct 01, 2001
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
K012176 · Ethicon Endo-Surgery, Inc.
LFL · Instrument, Ultrasonic Surgical · 81d

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All categories 7697 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1108 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