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
13991 General & Plastic Surgery devices
7726–7750 of 13991
Cleared Oct 30, 2003
ARTHROCARE ENT PLASMA WANDS
K033257 · Arthrocare Corp.
GEI · Electrosurgical, Cutting & Coagulation & Accessories · 21d
Cleared Oct 24, 2003
MODIFICATION TO SUTURE CLINCH
K033024 · Applied Medical Resources Corp.
FZP · Clip, Implantable · 28d
Cleared Oct 23, 2003
COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE
K032698 · Coapt Systems, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 51d
Cleared Oct 22, 2003
FERRIS POLYMEM SILVER WOUND DRESSING
K031307 · Ferris Mfg. Corp.
FRO · Dressing, Wound, Drug · 181d
Cleared Oct 22, 2003
PARIEFIX
K032093 · Sofradim Production
GCJ · Laparoscope, General & Plastic Surgery · 107d
Cleared Oct 22, 2003
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
K032420 · Ethicon, Inc.
GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 78d
Cleared Oct 22, 2003
CYNOSURE PHOTOGENICA VL
K032565 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 63d
Cleared Oct 15, 2003
MEDELA CLARIO HOME CARE PUMP
K033179 · Medela AG
BTA · Pump, Portable, Aspiration (manual Or Powered) · 14d
Cleared Oct 10, 2003
LASERSMILE
K030539 · Biolase Technology, Inc.
GEX · Powered Laser Surgical Instrument · 232d
Cleared Oct 10, 2003
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
K032310 · Kinetic Concepts, Inc.
OMP · Negative Pressure Wound Therapy Powered Suction Pump · 74d
Cleared Oct 09, 2003
CYNOSURE SMART FILE ND:YAG LASERS
K031125 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 183d
Cleared Oct 09, 2003
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES
K032357 · Lumenis, Inc.
GEX · Powered Laser Surgical Instrument · 71d
Cleared Oct 07, 2003
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · 3M Company
KMF · Bandage, Liquid · 169d
Cleared Oct 03, 2003
SONOSURG SYSTEM
K032066 · The Olympus Optical Co.
LFL · Instrument, Ultrasonic Surgical · 92d
Cleared Oct 03, 2003
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
K032085 · Nidek, Inc.
GEX · Powered Laser Surgical Instrument · 88d
Cleared Oct 02, 2003
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
K032344 · Implex Corp.
EZX · Mesh, Surgical, Metal · 64d
Cleared Oct 02, 2003
OPTICAL SEPARATOR
K032889 · Applied Medical Resources
GCJ · Laparoscope, General & Plastic Surgery · 15d
Cleared Oct 01, 2003
CYNOSURE SMART 2940D ER:YAG LASER
K031389 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 152d
Cleared Oct 01, 2003
SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER
K031440 · Cynosure, Inc.
GEX · Powered Laser Surgical Instrument · 148d
Cleared Oct 01, 2003
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
K032805 · Vascular Solutions, Inc.
GEX · Powered Laser Surgical Instrument · 22d
Cleared Sep 30, 2003
SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)
K032701 · Power Medical Interventions, Inc.
GDW · Staple, Implantable · 28d
Cleared Sep 29, 2003
DRESSSKIN
K023778 · Tei Biosciences, Inc.
KGN · Wound Dressing With Animal-derived Material(s) · 321d
Cleared Sep 26, 2003
SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045
K032680 · Smith & Nephew, Inc.
GCJ · Laparoscope, General & Plastic Surgery · 28d
Cleared Sep 23, 2003
OLYMPUS ULTRASONIC SURGICAL SYSTEM
K031305 · Olympus Optical Co., Ltd.
LFL · Instrument, Ultrasonic Surgical · 152d
Cleared Sep 22, 2003
MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET
K031955 · Macropore Biosurgery, Inc.
FTL · Mesh, Surgical, Polymeric · 89d

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All categories 13991 GEX Powered Laser Surgical Instrument 2370 GEI Electrosurgical, Cutting & Coagulation & Accessories 1867 GCJ Laparoscope, General & Plastic Surgery 1113 FRO Dressing, Wound, Drug 568 FTL Mesh, Surgical, Polymeric 316 GDW Staple, Implantable 256 GEH Unit, Cryosurgical, Accessories 210 OMP Negative Pressure Wound Therapy Powered Suction Pump 209 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 EFQ Gauze/sponge, Internal 157 GAT Suture, Nonabsorbable, Synthetic, Polyethylene 157 KMF Bandage, Liquid 155