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

14327 General & Plastic Surgery devices

14176–14200 of 14327

Cleared Mar 09, 1978

KALRN FACE-LIFE SCISSORS

K772394 · Edward Weck, Inc.

FZI · Apparatus, Air Handling, Enclosure · 72d

Cleared Mar 09, 1978

DAVIS RHYTIDECTOMY

K772395 · Edward Weck, Inc.

FZI · Apparatus, Air Handling, Enclosure · 72d

Cleared Feb 28, 1978

BRACHIAL-LARGE VESSEL APPROXIMATOR

K780286 · Edward Weck, Inc.

GDJ · Clamp, Surgical, General & Plastic Surgery · 7d

Cleared Feb 28, 1978

BRACHEAL-LARGE VESSEL CLIP

K780288 · Edward Weck, Inc.

GDJ · Clamp, Surgical, General & Plastic Surgery · 7d

Cleared Feb 28, 1978

ULNAR-RADIAL CLIP

K780290 · Edward Weck, Inc.

GDJ · Clamp, Surgical, General & Plastic Surgery · 7d

Cleared Feb 28, 1978

ULNAR-RADIAL APPROXIMATER

K780291 · Edward Weck, Inc.

GDJ · Clamp, Surgical, General & Plastic Surgery · 7d

Cleared Feb 28, 1978

ELECTRO-SURGICAL GROUNDING PAD

K780298 · Johnson & Johnson Professionals, Inc.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 6d

Cleared Feb 21, 1978

CUT-DOWN BUILT-UP TOILET SEAT

K772403 · Fred Sammons, Inc.

Cleared Feb 02, 1978

FACELIFT SCISSORS

K780152 · Edward Weck, Inc.

FZT · Cutter, Surgical · 3d

Cleared Feb 02, 1978

HOUSE SUCTION IRRIGATOR

K780153 · Edward Weck, Inc.

JYC · Cannula, Ear · 3d

Cleared Jan 31, 1978

CEMENT EXTRACTION INSTRUMENT SET

K780135 · Orthopedic Equipment Co., Inc.

KDG · Chisel (osteotome) · 7d

Cleared Jan 30, 1978

CATHETER, CHOLANGIOGRAM, OPERATIVE

K772288 · Gesco Intl., Inc.

GBZ · Catheter, Cholangiography · 49d

Cleared Jan 20, 1978

INSTRUMENT TRAY

K772266 · Med Fusion Systems, Inc.

FSM · Tray, Surgical, Instrument · 42d

Cleared Jan 17, 1978

BARRAQUER OVAL SPECULUM-VARIOUS SIZES

K772370 · Edward Weck, Inc.

EPY · Speculum, Ent · 21d

Cleared Jan 17, 1978

FARRIOR OVAL SPECULUM

K772380 · Edward Weck, Inc.

EPY · Speculum, Ent · 21d

Cleared Jan 17, 1978

THIN-BLADED NASAL SPECULUM

K772385 · Edward Weck, Inc.

EPY · Speculum, Ent · 21d

Cleared Jan 12, 1978

INTERMEDULLARY BRUSH

K771016 · Howmedica Corp.

HTR · Rasp · 220d

Cleared Dec 20, 1977

LAPAROSCOPY DRAPE, BOUNDARY

K772301 · Procter & Gamble Mfg. Co.

FZT · Cutter, Surgical · 6d

Cleared Dec 13, 1977

CAUTERIES, HOT WIRE, DISP.

K772199 · Intermedics, Inc.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 13d

Cleared Nov 30, 1977

IOPSY TRAY FOR SOFT TISSUE BIOPSY

K771784 · Bd Becton Dickinson Vacutainer Systems Preanalytic

GAA · Needle, Aspiration And Injection, Disposable · 68d

Cleared Nov 29, 1977

IRRIGATING NEEDLE, ILLUMINATED

K771785 · Concept, Inc.

Cleared Nov 28, 1977

LIGACLIP MULTIPLE CLIP APPLIER

K771412 · Ethicon, Inc.

GDO · Applier, Surgical, Clip · 119d

Cleared Nov 28, 1977

LIGACLIP MULTIPLE LIGATING CLIPS

K771413 · Ethicon, Inc.

FZP · Clip, Implantable · 119d

Cleared Nov 28, 1977

ARMOR-KOT SURGICAL INSTRUMENTS

K771680 · Storz Instrument Co.

FSM · Tray, Surgical, Instrument · 83d

Cleared Nov 28, 1977

CATHETER, CEBTRAL VENOUS, 2N1501

K771861 · Travenol Laboratories, S.A.

JCY · Catheter, Infusion · 56d

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