KOA · Class I · 21 CFR 876.4730

FDA Product Code KOA: Surgical Instruments, G-u, Manual (and Accessories)

Leading manufacturers include The Huxley Instrument Corp., Imm Enterprises , Ltd. and V. Mueller O.V. Baxter Healthcare Corp..

44
Total
44
Cleared
75d
Avg days
1976
Since

FDA 510(k) Cleared Surgical Instruments, G-u, Manual (and Accessories) Devices (Product Code KOA)

44 devices
1–24 of 44
Cleared Dec 07, 2018
FiXcision
K182664
Agency For Medical Innovations GmbH
Gastroenterology & Urology · 73d
Cleared Jan 31, 1995
URETHRAL SUTURE GUIDE
K950267
Applied Medical Resources
Gastroenterology & Urology · 8d
Cleared Jul 02, 1993
VASOVASOSTOMY SET
K921546
Cook Urological, Inc.
Gastroenterology & Urology · 457d
Cleared Sep 23, 1992
NO-SCALPEL VASCETOMY INSTRUMENTS
K922971
Pilling Co.
Gastroenterology & Urology · 96d
Cleared Aug 07, 1992
VAS DILATOR
K922192
Cook Urological, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 27, 1989
MICROSURGICAL CYSTOTOME
K890218
Kinetic Medical Products
Gastroenterology & Urology · 9d
Cleared Jul 09, 1985
BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420
K852725
The Huxley Instrument Corp.
Gastroenterology & Urology · 13d
Cleared Jul 09, 1985
ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420
K852726
The Huxley Instrument Corp.
Gastroenterology & Urology · 13d
Cleared Apr 15, 1985
AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER
K851162
Van-Tec, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 03, 1985
RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV
K851111
The Huxley Instrument Corp.
Gastroenterology & Urology · 15d
Cleared Apr 03, 1985
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
K851112
The Huxley Instrument Corp.
Gastroenterology & Urology · 15d
Cleared Apr 03, 1985
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR
K851113
The Huxley Instrument Corp.
Gastroenterology & Urology · 15d
Cleared May 09, 1984
WESTON RECTAL SNARE
K841387
Imm Enterprises , Ltd.
Gastroenterology & Urology · 43d
Cleared Apr 04, 1984
OP-CON SURG. INSTRUMENT #3
K834171
Imm Enterprises , Ltd.
Gastroenterology & Urology · 135d
Cleared Mar 22, 1984
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
K834191
Imm Enterprises , Ltd.
Gastroenterology & Urology · 122d
Cleared Mar 22, 1984
JAKOBI SURG. INSTRUMENTS #3 21/22/24
K834192
Imm Enterprises , Ltd.
Gastroenterology & Urology · 122d
Cleared Mar 20, 1984
PROBES, VARIOUS
K841003
Premier Dental Products Co.
Gastroenterology & Urology · 11d
Cleared Dec 08, 1983
P-S MEDICAL BERLIN VISADUCT KIT
K832677
Pudenz-Schulte Medical Research Corp.
Gastroenterology & Urology · 121d
Cleared May 21, 1981
VASOVASOSTOMY STABILIZER PLATFORM DEV
K811223
Biomet, Inc.
Gastroenterology & Urology · 17d
Cleared Oct 21, 1976
FLEXIBLE CUTTING SCISSORS
K760715
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 26d
Cleared Oct 21, 1976
FLEXIBLE BIOPSY FORCEPS
K760717
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 26d
Cleared Oct 15, 1976
FLEXIBLE FOREIGN BODY FORCEPS
K760716
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 20d

About Product Code KOA - Regulatory Context