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

18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
14022 General & Plastic Surgery devices
8201–8225 of 14022
Cleared Mar 01, 2001
CONTOUR PROFILE LASER
K010285 · Sciton, Inc
GEX · Powered Laser Surgical Instrument · 29d
Cleared Feb 28, 2001
ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP
K010444 · C.R. Bard, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 14d
Cleared Feb 22, 2001
VISULAS YAG II
K003885 · Carl Zeiss, Inc.
GEX · Powered Laser Surgical Instrument · 69d
Cleared Feb 22, 2001
ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP
K010007 · Taut, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 51d
Cleared Feb 21, 2001
GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
K010228 · W.L. Gore & Associates, Inc.
FTL · Mesh, Surgical, Polymeric · 28d
Cleared Jan 29, 2001
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
K003577 · STERIS Corporation
FST · Light, Surgical, Fiberoptic · 70d
Cleared Jan 25, 2001
TWILITE, TWILITE WHITE
K003385 · Biolase Technology, Inc.
GEX · Powered Laser Surgical Instrument · 86d
Cleared Jan 25, 2001
PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM
K003460 · Palomar Medical Technologies, Inc.
GEX · Powered Laser Surgical Instrument · 79d
Cleared Jan 25, 2001
DENLASER, MODEL 800
K003541 · CAO Group, Inc.
GEX · Powered Laser Surgical Instrument · 70d
Cleared Jan 24, 2001
SOFRADIM PARIETEX SURGICAL MESHES
K003990 · Sofradim Production
FTL · Mesh, Surgical, Polymeric · 29d
Cleared Jan 22, 2001
COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
K003323 · Davol, Inc.
FTL · Mesh, Surgical, Polymeric · 90d
Cleared Jan 04, 2001
ERBE APC HANDLE AND APPLICATORS, MODEL 20132-043,20132-031,20132-032,20132-033,20132-034,20132-040,20132-044,20132-045
K003462 · Erbe USA, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 58d
Cleared Dec 27, 2000
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738 · DePuy Orthopaedics, Inc.
FTM · Mesh, Surgical · 203d
Cleared Dec 22, 2000
AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
K001955 · Aaron Medical Industries
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 178d
Cleared Dec 22, 2000
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
K003790 · Davol, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 14d
Cleared Dec 20, 2000
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210
K002308 · Trimedyne, Inc.
GEX · Powered Laser Surgical Instrument · 145d
Cleared Dec 20, 2000
WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
K003100 · Boston Scientific Corp
JCT · Prosthesis, Tracheal, Expandable · 78d
Cleared Dec 20, 2000
REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702
K003624 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 26d
Cleared Dec 15, 2000
ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07
K002906 · Ethicon Endo-Surgery, Inc.
LFL · Instrument, Ultrasonic Surgical · 88d
Cleared Dec 15, 2000
SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
K003015 · Surgical Specialties Corp
GAN · Suture, Absorbable, Synthetic · 79d
Cleared Dec 15, 2000
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
K003147 · Laserscope
GEX · Powered Laser Surgical Instrument · 66d
Cleared Dec 08, 2000
AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER
K001895 · United States Surgical, A Division of Tyco Healthc
GDW · Staple, Implantable · 170d
Cleared Dec 08, 2000
THERMAGE THERMACOOL II SYSTEM
K003183 · Thermage, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 58d
Cleared Dec 08, 2000
NEZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS: J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, NEEDLE TIP, BALL TIP
K003674 · Davol Inc., Sub. C. R. Bard, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 9d
Cleared Dec 04, 2000
SCITON IMAGE HAIR REMOVAL LASER
K002853 · Sciton, Inc
GEX · Powered Laser Surgical Instrument · 82d

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All categories 14022 GEX Powered Laser Surgical Instrument 2373 GEI Electrosurgical, Cutting & Coagulation & Accessories 1872 GCJ Laparoscope, General & Plastic Surgery 1114 FRO Dressing, Wound, Drug 574 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 257 GEH Unit, Cryosurgical, Accessories 211 OMP Negative Pressure Wound Therapy Powered Suction Pump 211 KGN Wound Dressing With Animal-derived Material(s) 171 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 160 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 157 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155