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

14243 General & Plastic Surgery devices

12351–12375 of 14243

Cleared Apr 08, 1988

YESNG PATIENT PLATE #80226

K881144 · Ferguson Medical

JOS · Electrode, Electrosurgical · 22d

Cleared Apr 06, 1988

KOI(TM) INSTRUMENT TRAYS

K881095 · CooperVision, Inc.

LRP · Tray, Surgical · 22d

Cleared Apr 06, 1988

STERNUM SPREADER AND MITRAL VALVE RETRACTOR

K881157 · T. Korossurgical Instruments Corp.

GAD · Retractor · 19d

Cleared Apr 05, 1988

UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR

K881156 · T. Korossurgical Instruments Corp.

GAD · Retractor · 18d

Cleared Apr 05, 1988

I.M.A. RETRACTOR

K881159 · T. Korossurgical Instruments Corp.

GAD · Retractor · 18d

Cleared Apr 04, 1988

NOVO VIVO MODEL #17140 AND #17135

K880377 · Genesis Industries, Inc.

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

Cleared Apr 01, 1988

TEGASORB ULCER DRESSING #90-XXX

K872298 · 3M Company

FRO · Dressing, Wound, Drug · 291d

Cleared Apr 01, 1988

K881050 · Convatec, A Division of E.R. Squibb & Sons

NAD · Dressing, Wound, Occlusive · 21d

Cleared Mar 28, 1988

JOHNSON & JOHNSON FLUFF SPONGE

K881222 · Johnson & Johnson Professionals, Inc.

EFQ · Gauze/sponge, Internal · 6d

Cleared Mar 25, 1988

OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)

K881060 · Orthopedic Systems, Inc.

JEA · Table, Surgical With Orthopedic Accessories, Ac-powered · 21d

Cleared Mar 23, 1988

FERRIS HYDROPHILIC DRESSING

K880330 · Ferris Mfg. Corp.

FRO · Dressing, Wound, Drug · 56d

Cleared Mar 21, 1988

K880859 · New England Surgical Instrument Corp.

GFF · Bur, Surgical, General & Plastic Surgery · 20d

Cleared Mar 21, 1988

SPRING RETRACTOR

K880997 · T. Korossurgical Instruments Corp.

GAD · Retractor · 13d

Cleared Mar 21, 1988

STERNUM SPREADER, PEDIATRIC

K880998 · T. Korossurgical Instruments Corp.

GAD · Retractor · 13d

Cleared Mar 21, 1988

AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.

K881048 · Smith & Nephew, Inc.

FRO · Dressing, Wound, Drug · 10d

Cleared Mar 17, 1988

FLAT STICK SPONGE

K880851 · Ormed Mfg., Inc.

EFQ · Gauze/sponge, Internal · 16d

Cleared Mar 17, 1988

ROSEBUD DISSECTORS

K880852 · Ormed Mfg., Inc.

EFQ · Gauze/sponge, Internal · 16d

Cleared Mar 17, 1988

K880853 · Ormed Mfg., Inc.

EFQ · Gauze/sponge, Internal · 16d

Cleared Mar 17, 1988

STRUNG ABSORBENT BALLS

K880854 · Ormed Mfg., Inc.

EFQ · Gauze/sponge, Internal · 16d

Cleared Mar 17, 1988

TRIANGLE SPONGE

K880907 · Ormed Mfg., Inc.

EFQ · Gauze/sponge, Internal · 14d

Cleared Mar 17, 1988

TRACHEOTOMY SPONGES

K880909 · Ormed Mfg., Inc.

EFQ · Gauze/sponge, Internal · 14d

Cleared Mar 17, 1988

ROUND STICK SPONGES

K880910 · Ormed Mfg., Inc.

EFQ · Gauze/sponge, Internal · 14d

Cleared Mar 17, 1988

K880911 · Ormed Mfg., Inc.

EFQ · Gauze/sponge, Internal · 14d

Cleared Mar 15, 1988

OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION

K880263 · Orthopedic Systems, Inc.

JEB · Table, Surgical With Orthopedic Accessories, Manual · 53d

Cleared Mar 14, 1988

PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK

K875004 · Advanced Surgical Products, Inc.

FST · Light, Surgical, Fiberoptic · 101d

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