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

7733 General & Plastic Surgery devices

6551–6575 of 7733

Cleared Dec 02, 1987

MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER

K874503 · Micro-Aire Surgical Instruments, Inc.

HWM · Osteotome · 30d

Cleared Dec 02, 1987

AUTO SUTURE PURSE STRING APPLIER*

K874428 · United States Surgical, A Division of Tyco Healthc

GDJ · Clamp, Surgical, General & Plastic Surgery · 35d

Cleared Nov 27, 1987

REFLEX(TM) CA-T CLIP APPLIER

K873309 · Richard-Allan Medical Ind., Inc.

FZP · Clip, Implantable · 101d

Cleared Nov 20, 1987

SOFT TISSUE ANCHORING SET KIT

K874439 · Concept, Inc.

LRO · General Surgery Tray · 23d

Cleared Nov 17, 1987

COMFEEL ULCUS ULCER CARE SYSTEM

K873669 · Coloplast A/S

FRO · Dressing, Wound, Drug · 67d

Cleared Nov 17, 1987

STAINLESS 22-13-5 SUTURE WIRE

K873645 · Zimmer, Inc.

GAQ · Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile · 70d

Cleared Nov 13, 1987

ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000

K874243 · Pilling Co.

GAD · Retractor · 28d

Cleared Oct 28, 1987

CLOSED CHEST DRAINAGE SET W/SUTURES

K873377 · Gish Biomedical, Inc.

GBS · Catheter, Ventricular, General & Plastic Surgery · 65d

Cleared Oct 23, 1987

TECNOL SURGEON'S CAP

K873830 · Tecnol New Jersey Wound Care, Inc.

FYF · Cap, Surgical · 32d

Cleared Oct 23, 1987

SMITH & NEPHEW DAYLIGHTER(TM)

K873786 · Smith & Nephew, Inc.

FSY · Light, Surgical, Ceiling Mounted · 36d

Cleared Oct 07, 1987

CODMAN NEUROLASE LASER SYSTEM

K872179 · Codman & Shurtleff, Inc.

GEX · Powered Laser Surgical Instrument · 121d

Cleared Sep 30, 1987

K873744 · Beiersdorf, Inc.

FZQ · Clip, Removable (skin) · 14d

Cleared Sep 28, 1987

MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY

K872711 · Directed Energy, Inc.

GEX · Powered Laser Surgical Instrument · 83d

Cleared Sep 16, 1987

TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING

K872988 · Smith & Nephew, Inc.

NAD · Dressing, Wound, Occlusive · 47d

Cleared Sep 16, 1987

HEWSON A.C.L. GUIDE SET

K872608 · Concept, Inc.

KGS · Retention Device, Suture · 72d

Cleared Sep 04, 1987

STRETCH GAUZE BANDAGES

K872875 · Abco Dealers, Inc.

NAD · Dressing, Wound, Occlusive · 45d

Cleared Sep 04, 1987

AQUATULLE FINE MESH NON-ADHERING DRESSING

K872759 · Smith & Nephew, Inc.

EFQ · Gauze/sponge, Internal · 53d

Cleared Aug 17, 1987

CONCEPT SWITCHING STICK

K873009 · Concept, Inc.

KGZ · Accessories, Catheter · 13d

Cleared Aug 17, 1987

COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS

K872214 · CooperVision, Inc.

GEA · Cannula, Surgical, General & Plastic Surgery · 69d

Cleared Aug 14, 1987

JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING

K872982 · Johnson & Johnson Professionals, Inc.

NAD · Dressing, Wound, Occlusive · 14d

Cleared Aug 13, 1987

K872975 · Beiersdorf, Inc.

KGX · Tape And Bandage, Adhesive · 14d

Cleared Aug 11, 1987

LN 100 BREAST MARKER

K872319 · Instrumentation Industries, Inc.

FTY · Tape, Measuring, Rulers And Calipers · 55d

Cleared Aug 05, 1987

AUTO SUTURE STAINLESS STEEL SUTURES*

K872532 · United States Surgical, A Division of Tyco Healthc

GAO · Suture, Nonabsorbable · 40d

Cleared Aug 04, 1987

MODIFIED CURLCATH

K872787 · Quinton, Inc.

GBQ · Catheter, Continuous Irrigation · 22d

Cleared Jul 29, 1987

INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING

K872624 · Smith & Nephew, Inc.

FRO · Dressing, Wound, Drug · 23d

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