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
7645 General & Plastic Surgery devices
3951–3975 of 7645
Cleared Feb 22, 2008
SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM
K073466 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 74d
Cleared Feb 15, 2008
ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00
K080282 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 11d
Cleared Feb 14, 2008
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER
K070947 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 316d
Cleared Feb 12, 2008
REPROCESSED SCISSOR TIPS
K073613 · Sterilmed, Inc.
NUJ · Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed · 53d
Cleared Feb 11, 2008
MENISCAL CINCH
K073149 · Arthrex, Inc.
GAT · Suture, Nonabsorbable, Synthetic, Polyethylene · 95d
Cleared Feb 07, 2008
INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER
K072627 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 143d
Cleared Jan 31, 2008
CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER
K080121 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 14d
Cleared Jan 23, 2008
OPTILITE HOLMIUM LASER FIBERS
K073496 · Cook Urological, Inc.
GEX · Powered Laser Surgical Instrument · 42d
Cleared Jan 23, 2008
ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT
K073464 · AngioDynamics, Inc.
GEX · Powered Laser Surgical Instrument · 44d
Cleared Jan 10, 2008
VARI-LASE WIRE FIBER
K072332 · Vascular Solutions, Inc.
GEX · Powered Laser Surgical Instrument · 143d
Cleared Dec 27, 2007
CYNOSURE YAG FAMILY LASER
K072484 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 114d
Cleared Dec 12, 2007
SMARTLIPO LASER
K073394 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 9d
Cleared Dec 07, 2007
D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005
K073264 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 17d
Cleared Dec 07, 2007
ONEPORT SURGICAL TROCAR SYSTEM
K073009 · Conmed Corporation
GCJ · Laparoscope, General & Plastic Surgery · 43d
Cleared Nov 21, 2007
AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
K071406 · United States Surgical, A Division of Tyco Healthc
FZP · Clip, Implantable · 184d
Cleared Nov 09, 2007
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc.
FRO · Dressing, Wound, Drug · 77d
Cleared Nov 05, 2007
ACCOLADE II LASER
K072868 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 27d
Cleared Oct 23, 2007
MODIFICATON TO: ARTHROCARE ARTHROWANDS
K072865 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 18d
Cleared Oct 18, 2007
REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
K070930 · Sterilmed, Inc.
NLL · Staple, Implantable, Reprocessed · 198d
Cleared Oct 05, 2007
KII TROCAR SYSTEM
K072674 · Applied Medical Resources Corp.
GCJ · Laparoscope, General & Plastic Surgery · 14d
Cleared Oct 05, 2007
SUCTION COAGULATOR
K072559 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 24d
Cleared Oct 05, 2007
THROMBIX PATCH THROMBIN HEMOSTASIS PATCH
K072117 · Vascular Solutions, Inc.
QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 65d
Cleared Oct 05, 2007
HARMONY LED-1 SURGICAL LIGHTING SYSTEM
K072072 · STERIS Corporation
FSY · Light, Surgical, Ceiling Mounted · 67d
Cleared Oct 05, 2007
REFLECTION, TANDEM UNIPOLAR
K071160 · Smith & Nephew, Inc.
LPH · Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented · 162d
Cleared Sep 28, 2007
AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
K071920 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 78d

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All categories 7645 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 LFL Instrument, Ultrasonic Surgical 85 KGN Wound Dressing With Animal-derived Material(s) 85 GEH Unit, Cryosurgical, Accessories 78