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

18327

Total

18282

Cleared

139d

Avg (2y)

1976

Since

14255 General & Plastic Surgery devices

12751–12775 of 14255

Cleared May 02, 1986

SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC

K854998 · Directed Energy, Inc.

GEX · Powered Laser Surgical Instrument · 141d

Cleared May 02, 1986

SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT

K855210 · Directed Energy, Inc.

GEX · Powered Laser Surgical Instrument · 123d

Cleared Apr 30, 1986

ZEISS VOICE CONTROL SYSTEM FOR OPMI'S

K860811 · Carl Zeiss, Inc.

EPT · Microscope, Surgical · 57d

Cleared Apr 30, 1986

DIALET LANCING DEVICE

K861265 · Home Diagnostics, Inc.

FMK · Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature · 26d

Cleared Apr 29, 1986

NEONATAL UNILET

K861243 · Ulster Scientific, Inc.

FMK · Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature · 27d

Cleared Apr 24, 1986

SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM

K860087 · Sharplan Lasers, Inc.

GEX · Powered Laser Surgical Instrument · 105d

Cleared Apr 23, 1986

MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY

K860273 · Britt Corp., Inc.

GEX · Powered Laser Surgical Instrument · 86d

Cleared Apr 15, 1986

MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC

K860278 · Britt Corp., Inc.

GEX · Powered Laser Surgical Instrument · 78d

Cleared Apr 15, 1986

SUEL BLOOD LANCET

K861151 · Exel Intl.

FMK · Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature · 20d

Cleared Apr 10, 1986

BARD ABSORPTION DRESSING

K861024 · C.R. Bard, Inc.

FRO · Dressing, Wound, Drug · 23d

Cleared Apr 04, 1986

DONALDSON NATURAL EYEPATCH

K860979 · Keeler Instruments, Inc.

HMP · Pad, Eye · 21d

Cleared Apr 02, 1986

BIOPSY ADAPTER H4222W

K861050 · General Electric Co.

GDF · Guide, Needle, Surgical · 14d

Cleared Mar 28, 1986

MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM

K854386 · Directed Energy, Inc.

GEX · Powered Laser Surgical Instrument · 148d

Cleared Mar 28, 1986

OSTEO-MESH CRANIAL FAIRING

K860491 · Xomed, Inc.

Cleared Mar 28, 1986

VIDEO PRINTER, MODEL 3200

K860904 · Medline Industries, Inc.

KQM · Camera, Surgical And Accessories · 18d

Cleared Mar 26, 1986

ACTISORB ACTIVATED CHARCOAL DRESSING

K860486 · Johnson & Johnson Professionals, Inc.

FRO · Dressing, Wound, Drug · 44d

Cleared Mar 24, 1986

BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768

K860687 · Birtcher Corp.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 27d

Cleared Mar 24, 1986

ELECTROSURGERY PENCIL, MODEL 767

K860718 · Birtcher Corp.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 26d

Cleared Mar 21, 1986

AURORA M MEDICAL DYE LASER

K855246 · Cooper Lasersonics, Inc.

GEX · Powered Laser Surgical Instrument · 91d

Cleared Mar 10, 1986

BILE ENDOPROSTHESIS SET

K860534 · Angiomed U.S., Inc.

GBZ · Catheter, Cholangiography · 26d

Cleared Mar 04, 1986

K860582 · Hobbs Medical, Inc.

GAA · Needle, Aspiration And Injection, Disposable · 14d

Cleared Feb 25, 1986

SINGLE AND DUAL TOURNIQUET CUFF

K860463 · Aspen Laboratories, Inc.

KCY · Tourniquet, Pneumatic · 19d

Cleared Feb 19, 1986

ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY

K853877 · Endo Lase, Inc.

GEX · Powered Laser Surgical Instrument · 155d

Cleared Feb 19, 1986

ENDO-LASE CD 40 FOR DERMATOLOGY

K853901 · Endo Lase, Inc.

GEX · Powered Laser Surgical Instrument · 152d

Cleared Feb 19, 1986

ANGIO MED DISPOSABLE PRESSURE CONNECTORS

K855078 · Angiomed U.S., Inc.

KGZ · Accessories, Catheter · 62d

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