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
7701 General & Plastic Surgery devices
4626–4650 of 7701
Cleared Jul 10, 2000
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · Ethicon, Inc.
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 54d
Cleared Jul 06, 2000
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K001789 · W.L. Gore & Associates, Inc.
OXD · Mesh, Surgical, Non-absorbable, Staple Line Reinforcement · 23d
Cleared Jun 29, 2000
CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER
K992757 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 318d
Cleared Jun 27, 2000
AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
K001382 · Aaron Medical Industries
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 56d
Cleared Jun 07, 2000
ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL),
K001161 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 58d
Cleared Jun 07, 2000
HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL
K001159 · Conmedcorp
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 58d
Cleared Jun 05, 2000
CONMED TROGARD FINESSE TROCAR SYSTEM, MODEL 60-6050-XXX
K001597 · Conmedcorp
GCJ · Laparoscope, General & Plastic Surgery · 13d
Cleared Jun 05, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K000001 · Boston Scientific Scimed, Inc.
JCT · Prosthesis, Tracheal, Expandable · 154d
Cleared Jun 01, 2000
KSEA MANHES PNEUMOTROCAR
K000769 · KARL STORZ Endoscopy-America, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 84d
Cleared May 30, 2000
SOVEREIGN BIPOLAR INSTRUMENTS
K001330 · Aesculap, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 33d
Cleared May 30, 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C
K001302 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 36d
Cleared May 26, 2000
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K994260 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 161d
Cleared May 23, 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122 · Ethicon, Inc.
FTL · Mesh, Surgical, Polymeric · 46d
Cleared May 15, 2000
STRYKER IRRIGATION TUBE SET
K000493 · Stryker Endoscopy
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared May 03, 2000
ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
K000778 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 54d
Cleared May 02, 2000
SENTRY EXPANDING INTRODUCER SHEATH (EIS)
K000545 · Applied Medical Resources
GCJ · Laparoscope, General & Plastic Surgery · 74d
Cleared Apr 19, 2000
AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE
K000961 · Aaron Medical Industries
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 26d
Cleared Apr 17, 2000
MEDLINE TENDER WET WOUND DRESSING
K991755 · Medline Industries, Inc.
MGQ · Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic · 329d
Cleared Mar 30, 2000
MONOFILAMENT BIOSYN SUTURE
K000037 · United States Surgical, A Division of Tyco Healthc
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 84d
Cleared Mar 24, 2000
AESCULAP BONE WAX
K000021 · Aesculap, Inc.
MTJ · Wax, Bone · 80d
Cleared Mar 20, 2000
VISAGE COSMETIC SURGERY, MODEL V5000
K992180 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 266d
Cleared Mar 17, 2000
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
K994280 · Ethicon Endo-Surgery, Inc.
LFL · Instrument, Ultrasonic Surgical · 88d
Cleared Mar 13, 2000
DYONICS ELECTROBLADE
K994365 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 77d
Cleared Mar 13, 2000
MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS
K000511 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 26d
Cleared Mar 13, 2000
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
K000498 · Lumenis, Inc.
GEX · Powered Laser Surgical Instrument · 27d

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All categories 7701 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 103 FZP Clip, Implantable 100 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 93 KGN Wound Dressing With Animal-derived Material(s) 85 LFL Instrument, Ultrasonic Surgical 85 GEH Unit, Cryosurgical, Accessories 78