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
13997 General & Plastic Surgery devices
7801–7825 of 13997
Cleared Jun 18, 2003
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K030654 · Vascular Solutions, Inc.
GEX · Powered Laser Surgical Instrument · 107d
Cleared Jun 18, 2003
ANDIODYNAMICS, INC. ELVS PROCEDURE KIT
K031233 · AngioDynamics, Inc.
GEX · Powered Laser Surgical Instrument · 62d
Cleared Jun 13, 2003
PROFILE 1064 LASER SYSTEM
K023881 · Sciton, Inc
GEX · Powered Laser Surgical Instrument · 204d
Cleared Jun 05, 2003
MERDOC SYSTEM
K022393 · Stryker Endoscopy
GCJ · Laparoscope, General & Plastic Surgery · 317d
Cleared Jun 05, 2003
SCB COMPUTER MOTION INTERFACE CONTROLLER
K030718 · Computer Motion, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 90d
Cleared Jun 04, 2003
CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT
K030700 · Biolitec, Inc.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Jun 04, 2003
3-CCD DIGITAL CAMERA SYSTEM
K031098 · Linvatec Corp.
GCJ · Laparoscope, General & Plastic Surgery · 58d
Cleared Jun 04, 2003
CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER
K031488 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 23d
Cleared Jun 03, 2003
ULTRABLATOR ELECTRODE
K030720 · Linvatec Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 88d
Cleared May 29, 2003
LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500
K031011 · Valleylab, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 59d
Cleared May 29, 2003
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K031286 · Aesculap, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 36d
Cleared May 23, 2003
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM
K031117 · Galil Medical , Ltd.
GEH · Unit, Cryosurgical, Accessories · 45d
Cleared May 23, 2003
SAPHYRE BIPOLAR ABLATION PROBES
K031371 · Smith & Nephew, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 23d
Cleared May 22, 2003
CODMAN ISOCOOL BIPOLAR FORCEPS
K023566 · Codman & Shurtleff, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 211d
Cleared May 22, 2003
THERMACOOL TC SYSTEM
K031046 · Thermage, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 50d
Cleared May 22, 2003
SMART 2940 D ER: YAG LASER
K031317 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 27d
Cleared May 22, 2003
DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531
K031379 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 21d
Cleared May 21, 2003
COOL TOUCH 3
K031184 · New Star Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 36d
Cleared May 19, 2003
ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH
K030631 · Prosurg, Inc.
FTL · Mesh, Surgical, Polymeric · 80d
Cleared May 19, 2003
MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD
K031285 · Megadyne Medical Products, Inc.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 26d
Cleared May 15, 2003
COLLAGEN TOPICAL WOUND DRESSING
K030921 · Collagen Matrix, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 52d
Cleared May 15, 2003
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
K030925 · Ethicon Endo-Surgery, Inc.
GDW · Staple, Implantable · 52d
Cleared May 15, 2003
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
K031332 · C.R. Bard, Inc.
FTM · Mesh, Surgical · 17d
Cleared May 14, 2003
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
K030512 · Guidant Corp.
GCJ · Laparoscope, General & Plastic Surgery · 84d
Cleared May 12, 2003
COOLTOUCH ND: YAG LASER SYSTEM
K030453 · New Star Lasers, Inc.
GEX · Powered Laser Surgical Instrument · 90d

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All categories 13997 GEX Powered Laser Surgical Instrument 2370 GEI Electrosurgical, Cutting & Coagulation & Accessories 1869 GCJ Laparoscope, General & Plastic Surgery 1113 FRO Dressing, Wound, Drug 569 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 257 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 210 KGN Wound Dressing With Animal-derived Material(s) 170 NAY System, Surgical, Computer Controlled Instrument 163 OHT Light Based Over-the-counter Hair Removal 162 OHS Light Based Over The Counter Wrinkle Reduction 159 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 157 EFQ Gauze/sponge, Internal 157 KMF Bandage, Liquid 155