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
3851–3875 of 7643
Cleared Apr 16, 2009
PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS
K090631 · PAJUNK GmbH Medizintechnologie
GCJ · Laparoscope, General & Plastic Surgery · 38d
Cleared Apr 14, 2009
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
K090618 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 36d
Cleared Apr 08, 2009
PROWICK
K083007 · Arthrex, Inc.
FRO · Dressing, Wound, Drug · 182d
Cleared Mar 27, 2009
GORE BIO-A FISTULA PLUG
K083266 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 142d
Cleared Mar 20, 2009
STERIS CMAX XLT SURGICAL TABLE
K090136 · STERIS Corporation
FQO · Table, Operating-room, Ac-powered · 58d
Cleared Mar 19, 2009
AFFIRM CO2 AND AFFIRM CO2 HP
K081424 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 303d
Cleared Mar 18, 2009
ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U
K090547 · C.R. Bard, Inc.
NEU · Marker, Radiographic, Implantable · 16d
Cleared Mar 17, 2009
ELITE MPX LASER SYSTEM WITH XPL HANDPIECE
K090235 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 43d
Cleared Mar 17, 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141 · B.Braun Medical, Inc.
FRO · Dressing, Wound, Drug · 55d
Cleared Mar 06, 2009
ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE
K090084 · Merit Medical Systems, Inc.
GEX · Powered Laser Surgical Instrument · 53d
Cleared Mar 02, 2009
ATRICURE CRYO1 CRYO-ABLATION PROBE
K082074 · AtriCure, Inc.
GEH · Unit, Cryosurgical, Accessories · 222d
Cleared Feb 25, 2009
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375 · Smith & Nephew, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 103d
Cleared Feb 25, 2009
EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-
K083281 · Linvatec Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 110d
Cleared Feb 18, 2009
GELPORT SINGLE INCISION ACCESS SYSTEM
K090275 · Applied Medical Resources Corp.
GCJ · Laparoscope, General & Plastic Surgery · 14d
Cleared Feb 18, 2009
AXXION LIGHT GUIDE
K082992 · Spinal Elements, Inc.
FST · Light, Surgical, Fiberoptic · 134d
Cleared Feb 18, 2009
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
K081137 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 303d
Cleared Feb 12, 2009
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
K083500 · Dornier Medtech America, Inc.
GEX · Powered Laser Surgical Instrument · 79d
Cleared Jan 30, 2009
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
K083258 · Dornier Medtech America, Inc.
GEX · Powered Laser Surgical Instrument · 87d
Cleared Jan 29, 2009
RELIEVA STRATUS MICROFLOW SPACER
K083574 · Acclarent, Inc.
KAM · Cannula, Sinus · 57d
Cleared Jan 28, 2009
SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022
K083528 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 61d
Cleared Jan 21, 2009
CYNOSURE SMARTLIPO MPX LASER
K083795 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 30d
Cleared Jan 16, 2009
VIRTUOSAPH (TM) ENDOSCOPIC VEIN HARVESTING DISPOSABLE SYSTEM, MODEL MCVS550
K083194 · Terumo Cardiovascular Systems Corp.
GCJ · Laparoscope, General & Plastic Surgery · 79d
Cleared Jan 15, 2009
ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505
K082955 · Ethicon Endo-Surgery, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 104d
Cleared Jan 15, 2009
NUVASIVE SURGICAL MESH SYSTEM
K081377 · Nuvasive, Inc.
FTL · Mesh, Surgical, Polymeric · 244d
Cleared Jan 14, 2009
ATRIUM PROLITE S MESH
K082748 · Atrium Medical Corp.
FTL · Mesh, Surgical, Polymeric · 117d

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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