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
7652 General & Plastic Surgery devices
4151–4175 of 7652
Cleared Sep 14, 2005
AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM
K050382 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 211d
Cleared Sep 02, 2005
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
K050411 · Zimmer, Inc.
KCY · Tourniquet, Pneumatic · 197d
Cleared Aug 30, 2005
LUMENIS 1000 INTEGRATED SLIT LAMP
K052129 · Lumenis, Inc.
GEX · Powered Laser Surgical Instrument · 25d
Cleared Aug 30, 2005
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K051421 · Medical Device Technologies, Inc.
NEU · Marker, Radiographic, Implantable · 90d
Cleared Aug 30, 2005
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K051301 · Ethicon Endo-Surgery, Inc.
GDW · Staple, Implantable · 103d
Cleared Aug 17, 2005
PENUMBRA ASPIRATION PUMP, MODEL 115V
K051758 · Penumbra, Inc.
BTA · Pump, Portable, Aspiration (manual Or Powered) · 49d
Cleared Aug 11, 2005
SCB/STERIS OR-LIGHT INTERFACE BOX
K051505 · KARL STORZ Endoscopy-America, Inc.
FTA · Light, Surgical, Accessories · 65d
Cleared Aug 09, 2005
ENDOSCOPIC APPLICATOR
K051732 · Ethicon, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 42d
Cleared Jul 29, 2005
VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K051287 · Vascular Solutions, Inc.
GEX · Powered Laser Surgical Instrument · 72d
Cleared Jul 27, 2005
ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES
K051509 · Erbe USA, Inc.
GEH · Unit, Cryosurgical, Accessories · 50d
Cleared Jul 13, 2005
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY
K051359 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 50d
Cleared Jul 07, 2005
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
K050832 · Bard Peripheral Vascular, Inc.
JCT · Prosthesis, Tracheal, Expandable · 97d
Cleared Jun 29, 2005
MONOCRYL PLUS ANTIBACTERIAL SUTURE
K050845 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 86d
Cleared Jun 29, 2005
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
K050802 · Intuitive Surgical, Inc.
NAY · System, Surgical, Computer Controlled Instrument · 91d
Cleared Jun 27, 2005
CYNERGY MULTIPLEX LASER
K050779 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 91d
Cleared Jun 17, 2005
AMS COLLAGEN DERMAL MATRIX
K050445 · American Medical Systems, Inc.
PAG · Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 115d
Cleared Jun 13, 2005
CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
K050673 · Candela Corp.
GEX · Powered Laser Surgical Instrument · 90d
Cleared Jun 09, 2005
VELASMOOTH, SHAPER
K050397 · Syneron Medical, Ltd.
NUV · Massager, Vacuum, Light Induced Heating · 113d
Cleared Jun 09, 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc.
FRO · Dressing, Wound, Drug · 302d
Cleared Jun 08, 2005
IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677
K051125 · Abbott Laboratories
FZP · Clip, Implantable · 36d
Cleared Jun 06, 2005
REPROCESSED ULTRASONIC SCALPELS
K043358 · Alliance Medical Corp.
NLQ · Single-use Reprocessed Ultrasonic Surgical Instruments · 182d
Cleared Jun 03, 2005
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG
K050885 · Olympus Medical Systems Corporation
LFL · Instrument, Ultrasonic Surgical · 57d
Cleared Jun 02, 2005
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
K051036 · Ethicon Endo-Surgery, Inc.
LFL · Instrument, Ultrasonic Surgical · 38d
Cleared Jun 01, 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · United States Surgical, A Division of Tyco Healthc
GAW · Suture, Nonabsorbable, Synthetic, Polypropylene · 47d
Cleared May 27, 2005
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
K050453 · Ivoclar Vivadent, Inc.
GEX · Powered Laser Surgical Instrument · 94d

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All categories 7652 GEX Powered Laser Surgical Instrument 1148 GEI Electrosurgical, Cutting & Coagulation & Accessories 1106 GCJ Laparoscope, General & Plastic Surgery 682 FRO Dressing, Wound, Drug 216 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 100 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