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

14254 General & Plastic Surgery devices

12701–12725 of 14254

Cleared Aug 14, 1986

NEWMAN CANNULAE SYSTEM (NCS)

K862936 · Byron Medical

GEA · Cannula, Surgical, General & Plastic Surgery · 10d

Cleared Aug 14, 1986

LASER PLUME FILTERS

K862954 · Lifestream Int'L, Inc.

Cleared Aug 12, 1986

COOPER LASER SONICS ND: YAG LASER, MODEL 8008

K853117 · Cooper Lasersonics, Inc.

GEX · Powered Laser Surgical Instrument · 383d

Cleared Aug 12, 1986

OSTEOTOMY DRAINAGE TUBE

K862584 · Treace Medical, Inc.

GBS · Catheter, Ventricular, General & Plastic Surgery · 36d

Cleared Aug 12, 1986

ALMORE FACE MASK

K862851 · Almore Intl., Inc.

Cleared Aug 11, 1986

SPUNGUARD HOSPITAL COVERALL

K862804 · Kimberly-Clark Corp.

Cleared Aug 11, 1986

MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR

K862852 · Micro-Aire Surgical Instruments, Inc.

GFF · Bur, Surgical, General & Plastic Surgery · 13d

Cleared Aug 07, 1986

SILICONE SUMP DRAIN

K862767 · Sil-Med Corp.

GBS · Catheter, Ventricular, General & Plastic Surgery · 16d

Cleared Aug 04, 1986

HOLLISTER WOUND CARE BARRIER

K862572 · Hollister, Inc.

FRO · Dressing, Wound, Drug · 28d

Cleared Jul 30, 1986

TREACE MEDICAL MICRO INSTRUMENT WIPE

K862582 · Treace Medical, Inc.

Cleared Jul 30, 1986

JEDMED CCD CAMERA SYSTEM

K862664 · Jedmed Instrument Co.

FWD · Camera, Television, Microsurgical, Without Audio · 16d

Cleared Jul 30, 1986

TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP

K862696 · Downs Surgical , Ltd.

HBT · Applier, Hemostatic Clip · 15d

Cleared Jul 23, 1986

ELECTRO-SURGICAL PENCILS

K861742 · Stryker Corp.

GEI · Electrosurgical, Cutting & Coagulation & Accessories · 78d

Cleared Jul 23, 1986

REFLEX(TM) CLIP APPLIER

K862404 · Richard-Allan Medical Ind., Inc.

FZP · Clip, Implantable · 28d

Cleared Jul 23, 1986

CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE

K862481 · CIVCO Medical Instruments Co., Inc.

GDM · Needle, Aspiration And Injection, Reusable · 23d

Cleared Jul 23, 1986

STERILE DISPOSABLE TROCAR-SLEEVE DEVICES

K862611 · United States Surgical, A Division of Tyco Healthc

GCJ · Laparoscope, General & Plastic Surgery · 15d

Cleared Jul 21, 1986

LITE TOUCH GELFOAM INSERT

K862583 · Treace Medical, Inc.

Cleared Jul 10, 1986

K861142 · Pro-Lab, Inc.

LRP · Tray, Surgical · 106d

Cleared Jul 09, 1986

JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS

K862163 · Johnson & Johnson Professionals, Inc.

FRO · Dressing, Wound, Drug · 33d

Cleared Jul 08, 1986

MEDSURG CUSTOM DRESSING TRAYS

K861693 · Medsurg Industries, Inc.

Cleared Jul 08, 1986

ARMBOARDS, REUSABLE AND DISPOSABLE

K862111 · Abco Dealers, Inc.

Cleared Jul 08, 1986

CATALOG NO. I/A 100 AND KPE 200

K862334 · Ipax, Inc.

Cleared Jul 07, 1986

MODEL 545-45 LASER FOR DERMA., POD., SURGICAL

K860974 · Britt Corp., Inc.

GEX · Powered Laser Surgical Instrument · 115d

Cleared Jul 03, 1986

CONCORD CARE TRAY

K862039 · Concord Laboratories, Inc.

Cleared Jul 01, 1986

NON-ADHERING DRESSING WITH POVIDONE-IODINE

K861384 · Johnson & Johnson Professionals, Inc.

FRO · Dressing, Wound, Drug · 78d

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

Search all General & Plastic Surgery 510(k) devices