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

137d

Avg (2y)

1976

Since

7661 General & Plastic Surgery devices

4301–4325 of 7661

Cleared Nov 17, 2003

K033115 · Teleflex Medical

GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 48d

Cleared Nov 17, 2003

CAPROSYN ABSORBABLE SUTURE

K032586 · United States Surgical, A Division of Tyco Healthc

GAM · Suture, Absorbable, Synthetic, Polyglycolic Acid · 87d

Cleared Nov 17, 2003

CYNOSURE PHOTOGENICA SV LASER

K032539 · Cynosure, Inc.

GEX · Powered Laser Surgical Instrument · 91d

Cleared Nov 17, 2003

AURA ISURGICAL LASER SYSTEM & ACCESSORIES

K024206 · Laserscope

GEX · Powered Laser Surgical Instrument · 332d

Cleared Oct 30, 2003

ARTHROCARE ENT PLASMA WANDS

K033257 · Arthrocare Corp.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 21d

Cleared Oct 30, 2003

CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS

K033172 · Candela Corp.

GEX · Powered Laser Surgical Instrument · 30d

Cleared Oct 30, 2003

ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR

K032676 · Ethicon Endo-Surgery, Inc.

GCJ · Laparoscope, General & Plastic Surgery · 62d

Cleared Oct 24, 2003

MODIFICATION TO SUTURE CLINCH

K033024 · Applied Medical Resources Corp.

FZP · Clip, Implantable · 28d

Cleared Oct 22, 2003

CYNOSURE PHOTOGENICA VL

K032565 · Cynosure, Inc.

GEX · Powered Laser Surgical Instrument · 63d

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

K032093 · Sofradim Production

GCJ · Laparoscope, General & Plastic Surgery · 107d

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

NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES

K032357 · Lumenis, Inc.

GEX · Powered Laser Surgical Instrument · 71d

Cleared Oct 09, 2003

CYNOSURE SMART FILE ND:YAG LASERS

K031125 · Cynosure, Inc.

GEX · Powered Laser Surgical Instrument · 183d

Cleared Oct 07, 2003

3M LIQUID BANDAGE, MODEL 120-LB

K031263 · 3M Company

KMF · Bandage, Liquid · 169d

Cleared Oct 03, 2003

GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000

K032085 · Nidek, Inc.

GEX · Powered Laser Surgical Instrument · 88d

Cleared Oct 02, 2003

OPTICAL SEPARATOR

K032889 · Applied Medical Resources

GCJ · Laparoscope, General & Plastic Surgery · 15d

Cleared Oct 02, 2003

THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330

K032344 · Implex Corp.

EZX · Mesh, Surgical, Metal · 64d

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 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

CYNOSURE SMART 2940D ER:YAG LASER

K031389 · Cynosure, Inc.

GEX · Powered Laser Surgical Instrument · 152d

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 17, 2003

PROCEED TRILAMINATE SURGICAL MESH

K031925 · Ethicon, Inc.

FTL · Mesh, Surgical, Polymeric · 86d

Cleared Sep 17, 2003

D-STAT-DRY HEMOSTATIC BANDAGE

K030836 · Vascular Solutions, Inc.

QSX · Hemostatic Wound Dressing With Thrombin Or Other Biologics · 184d

Cleared Sep 16, 2003

CANDELA SMOOTHBEAM LASER SYSTEM

K030846 · Candela Corp.

GEX · Powered Laser Surgical Instrument · 183d

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