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

14249 General & Plastic Surgery devices

12601–12625 of 14249

Cleared Jan 08, 1987

MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR

K864851 · Valleylab, Inc.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 29d

Cleared Dec 30, 1986

MEDSURG VASCULAR ACCESS PORT INFUSION TRAY

K864495 · Medsurg Industries, Inc.

Cleared Dec 29, 1986

TRICOTEX WOUND CONTACT LAYER DRESSING

K864264 · Smith & Nephew, Inc.

NAB · Gauze / Sponge,nonresorbable For External Use · 61d

Cleared Dec 29, 1986

COLLINS POSITIONING DEVICE

K864880 · Orthopedic Systems, Inc.

FWZ · Operating Room Accessories Table Tray · 17d

Cleared Dec 29, 1986

ARTHROSCOPIC ANKLE HOLDER

K864881 · Orthopedic Systems, Inc.

FWZ · Operating Room Accessories Table Tray · 17d

Cleared Dec 24, 1986

INFECTIOUS TISSUE KIT

K864824 · American Scientific Products

Cleared Dec 23, 1986

BIOPSY ADAPTER #H4221BG

K864551 · General Electric Co.

GDF · Guide, Needle, Surgical · 34d

Cleared Dec 18, 1986

VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER

K864350 · Ethicon, Inc.

FZP · Clip, Implantable · 44d

Cleared Dec 18, 1986

STERILITE STERILIZATION KIT

K864596 · Kimberly-Clark Corp.

Cleared Dec 17, 1986

MEDSURG CUSTOM SURGICAL SCRUB TRAYS

K864463 · Medsurg Industries, Inc.

Cleared Dec 12, 1986

RAYLOR(TM) DISSECTING HOOK

K864425 · Cedar Surgical, Inc.

GDG · Hook, Surgical, General & Plastic Surgery · 32d

Cleared Dec 04, 1986

3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)

K861985 · 3M Company

MVR · Device, Anastomotic, Microvascular · 196d

Cleared Dec 04, 1986

SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG

K863086 · Cooper Lasersonics, Inc.

GEX · Powered Laser Surgical Instrument · 114d

Cleared Dec 01, 1986

VISCOPASTE ZINC PASTE BANDAGE

K863930 · Smith & Nephew, Inc.

FRO · Dressing, Wound, Drug · 54d

Cleared Dec 01, 1986

CARBONET ODOUR ADSORBING DRESSING

K863931 · Smith & Nephew, Inc.

Cleared Nov 26, 1986

RAYLOR(TM) PERIOSTEAL ELEVATORS

K864421 · Cedar Surgical, Inc.

GEG · Elevator, Surgical, General & Plastic Surgery · 16d

Cleared Nov 26, 1986

RAYLOR(TM) PROTECTIVE RETRACTOR

K864424 · Cedar Surgical, Inc.

GAD · Retractor · 16d

Cleared Nov 22, 1986

EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES

K864011 · Fraass Survival Systems, Inc.

NAD · Dressing, Wound, Occlusive · 38d

Cleared Nov 21, 1986

LYOFOAM C ODOR-ABSORBING DRESSING

K864084 · Acme United Corp.

FRO · Dressing, Wound, Drug · 32d

Cleared Nov 20, 1986

CANDELA MODEL SPT-1, PULSED DYE LASER

K861179 · Candela Corp.

GEX · Powered Laser Surgical Instrument · 234d

Cleared Nov 17, 1986

LASER SURGICAL ROD

K862815 · Lifestream Int'L, Inc.

GEX · Powered Laser Surgical Instrument · 116d

Cleared Nov 17, 1986

LEUKOPLAST(R) POROUS AND SPORT TAPE

K864160 · Beiersdorf, Inc.

KGX · Tape And Bandage, Adhesive · 25d

Cleared Nov 14, 1986

CHESEBROUGH POND'S HYDROCOLLOID DRESSING

K862803 · Chesebrough-Pond'S U.S.A. Co.

FRO · Dressing, Wound, Drug · 115d

Cleared Nov 14, 1986

TENSOTAPE SURGICAL ADHESIVE TAPE

K863865 · Smith & Nephew, Inc.

Cleared Nov 07, 1986

EYE PAD, COTTON, GAUZE COVERED

K864023 · Fraass Survival Systems, Inc.

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

Search all General & Plastic Surgery 510(k) devices