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
7643 General & Plastic Surgery devices
3876–3900 of 7643
Cleared Jan 09, 2009
REPROCESSED HARMONIC SCALPEL
K083060 · Sterilmed, Inc.
NLQ · Single-use Reprocessed Ultrasonic Surgical Instruments · 87d
Cleared Jan 02, 2009
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
K082396 · C.R. Bard, Inc.
GDW · Staple, Implantable · 136d
Cleared Dec 31, 2008
ERBE MODEL VIO 300 D WITH ACCESSORIES
K083452 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 40d
Cleared Dec 23, 2008
FIXATION TROCARS
K083638 · Applied Medical Resources Corp.
GCJ · Laparoscope, General & Plastic Surgery · 14d
Cleared Dec 23, 2008
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
K083613 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 15d
Cleared Dec 19, 2008
3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE
K082643 · Depuy Mitek, A Johnson & Johnson Company
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 99d
Cleared Dec 19, 2008
INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE
K081207 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 234d
Cleared Dec 18, 2008
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
K082809 · Lumenis, Inc.
GEX · Powered Laser Surgical Instrument · 85d
Cleared Dec 16, 2008
MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
K080741 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 274d
Cleared Dec 12, 2008
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
K083379 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 28d
Cleared Dec 10, 2008
MODIFICATION TO ARTHROCARE ARTHROWANDS
K083306 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 30d
Cleared Dec 09, 2008
PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001
K083013 · Gyrus Acmi, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 61d
Cleared Nov 14, 2008
ULTRAWAVE III EX 1320
K083207 · Quanta System Spa
GEX · Powered Laser Surgical Instrument · 14d
Cleared Nov 14, 2008
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS
K082322 · Covidien
GCJ · Laparoscope, General & Plastic Surgery · 93d
Cleared Nov 14, 2008
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
K082211 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 100d
Cleared Nov 12, 2008
D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015
K083190 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 14d
Cleared Nov 05, 2008
ARTHROCARE ARTHROWANDS
K082980 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 30d
Cleared Oct 21, 2008
E-Z CLEAN ELECTROSURGICAL ELECTRODE
K081791 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 118d
Cleared Oct 17, 2008
COLLAMEND FM IMPLANT
K082687 · C.R. Bard, Inc.
FTM · Mesh, Surgical · 32d
Cleared Oct 16, 2008
STRAIGHT FIRE HOLMIUM LASER FIBER
K082928 · Boston Scientific Corp
GEX · Powered Laser Surgical Instrument · 15d
Cleared Oct 15, 2008
ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS
K082666 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 33d
Cleared Oct 02, 2008
STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)
K081995 · Stryker Endoscopy
GCJ · Laparoscope, General & Plastic Surgery · 80d
Cleared Sep 29, 2008
VENTRIO HERNIA PATCH
K081777 · C.R. Bard, Inc.
FTL · Mesh, Surgical, Polymeric · 98d
Cleared Sep 17, 2008
MATRIX RF APPLICATOR
K073572 · Syneron Medical, Ltd.
GEX · Powered Laser Surgical Instrument · 273d
Cleared Sep 10, 2008
ADAPT UNIVERSAL LAPAROSCOPIC PORT, MODEL 405940, 405912, 40591213
K082156 · Teleflex Medical
GCJ · Laparoscope, General & Plastic Surgery · 42d

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All categories 7643 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1106 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 215 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 98 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