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

6576–6600 of 7733

Cleared Jul 28, 1987

LPM-1 (LASER POWER METER)

K871619 · Bio-Tek Instruments, Inc.

GEX · Powered Laser Surgical Instrument · 92d

Cleared Jul 24, 1987

CUTINOVA(R) PLUS FOAM GELFILM

K864913 · Beiersdorf, Inc.

FRO · Dressing, Wound, Drug · 220d

Cleared Jul 23, 1987

1.1 SCREWDRIVERS

K872490 · Micro-Aire Surgical Instruments, Inc.

LRZ · Screwdriver, Surgical · 30d

Cleared Jul 21, 1987

RGB CAMERA SYSTEM

K872661 · Aspen Laboratories, Inc.

FWF · Camera, Television, Endoscopic, Without Audio · 14d

Cleared Jul 16, 1987

1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS

K872491 · Micro-Aire Surgical Instruments, Inc.

GEG · Elevator, Surgical, General & Plastic Surgery · 23d

Cleared Jul 09, 1987

CLOSED CHEST DRAINAGE SET

K871873 · Gish Biomedical, Inc.

LRO · General Surgery Tray · 57d

Cleared Jun 26, 1987

AMERICAN PHARMASEAL WOUND DRESSING

K871770 · American Pharmaseal Div. Ahsc

FRO · Dressing, Wound, Drug · 51d

Cleared Jun 23, 1987

CUSA SYSTEM 200 MACRO-DISSECTOR

K864983 · Cooper Lasersonics, Inc.

LFL · Instrument, Ultrasonic Surgical · 183d

Cleared Jun 16, 1987

ALLEVYN HYDROPHILIC POLYURETHANE DRESSING

K871166 · Smith & Nephew, Inc.

NAD · Dressing, Wound, Occlusive · 84d

Cleared Jun 12, 1987

MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.

K871077 · Radionics, Inc.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 86d

Cleared May 26, 1987

MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT

K870971 · Directed Energy, Inc.

GEX · Powered Laser Surgical Instrument · 77d

Cleared May 26, 1987

MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT

K870970 · Directed Energy, Inc.

GEX · Powered Laser Surgical Instrument · 77d

Cleared May 26, 1987

MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE

K870838 · Directed Energy, Inc.

GEX · Powered Laser Surgical Instrument · 89d

Cleared May 26, 1987

MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE

K870837 · Directed Energy, Inc.

GEX · Powered Laser Surgical Instrument · 89d

Cleared May 11, 1987

BARD EMS SYSTEM 6000 E.S.U.

K871435 · C.R. Bard, Inc.

HAM · Apparatus, Electrosurgical · 28d

Cleared May 08, 1987

BANDAGES CATALOG NUMBER: 101 TO 220

K871495 · I M, Inc.

NAD · Dressing, Wound, Occlusive · 22d

Cleared Apr 10, 1987

MEDSURG BONE MARROW BIOPSY/ASPIRATION TRAY

K870894 · Medsurg Industries, Inc.

Cleared Apr 10, 1987

MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY

K870892 · Medsurg Industries, Inc.

FSM · Tray, Surgical, Instrument · 36d

Cleared Apr 10, 1987

SURGICAL STARTER KIT

K870744 · Devon Industries, Inc.

Cleared Apr 09, 1987

MODEL LS 840, CO2 LASER

K864563 · Cooper Lasersonics, Inc.

GEX · Powered Laser Surgical Instrument · 141d

Cleared Apr 09, 1987

MODEL LS 860, CO2 LASER

K864562 · Cooper Lasersonics, Inc.

GEX · Powered Laser Surgical Instrument · 141d

Cleared Apr 07, 1987

HAND SURGERY TABLE EXTENSION

K871225 · Orthopedic Systems, Inc.

FWZ · Operating Room Accessories Table Tray · 11d

Cleared Apr 06, 1987

MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.

K870149 · Radionics, Inc.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 83d

Cleared Apr 03, 1987

MVS FIBEROPTIC LIGHTPIPE

K870942 · Advanced Surgical Products, Inc.

FST · Light, Surgical, Fiberoptic · 25d

Cleared Mar 31, 1987

THE GRIPPER SEAL(TM)

K870900 · Pharmacia Deltec, Inc.

KGX · Tape And Bandage, Adhesive · 26d

Looking for a specific general & plastic surgery device? Search by device name, K-number or manufacturer.

Search all General & Plastic Surgery 510(k) devices