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 Lone Star Medical Products, Inc..

44
Total
44
Cleared
75d
Avg days
1976
Since
44 devices
25–44 of 44
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 18, 1983
DISIMETRIC RELEASE OF INSTRANETICS RAD
K830786
American Convertors Div., American Pharmaseal
Gastroenterology & Urology · 68d
Cleared Aug 27, 1982
ST. MARK'S RECTAL BIOPSY FORCEPS
K822401
Keymed, Inc.
Gastroenterology & Urology · 17d
Cleared Feb 22, 1982
URETHAL CUTTER CLAMP
K820015
Lone Star Medical Products, Inc.
Gastroenterology & Urology · 48d
Cleared Jan 07, 1982
ACESSORY TO MODIFIED FREEDING JEJUNOSTO
K813504
Midwest Metabolic Support Group
Gastroenterology & Urology · 23d
Cleared Jul 31, 1981
FORDER RETRACTOR
K811973
Surgemed Marketing, Inc.
Gastroenterology & Urology · 21d
Cleared Jun 26, 1981
FORDER RETRACTOR
K811693
Dacomed Corp.
Gastroenterology & Urology · 11d
Cleared May 21, 1981
VASOVASOSTOMY STABILIZER PLATFORM DEV
K811223
Biomet, Inc.
Gastroenterology & Urology · 17d
Cleared May 08, 1981
THE SCOTT DIALMENZENSERT
K810915
Lone Star Medical Products, Inc.
Gastroenterology & Urology · 32d
Cleared Mar 11, 1981
CIRCLE NEPHROSTOMY TUBE INTRODUCER
K810533
American V. Mueller
Gastroenterology & Urology · 13d
Cleared Dec 30, 1980
THE INQUINAL RESORVOIR INSERTER
K802983
Lone Star Medical Products, Inc.
Gastroenterology & Urology · 39d
Cleared Jul 28, 1980
MAGILL CATHETER INTRO. FORCEPS
K801273
J. Sklar Mfg. Co., Inc.
Gastroenterology & Urology · 60d
Cleared Apr 08, 1980
RUDD-CLINIC HEMORRHOIDAL FORCEPS
K800441
J. Sklar Mfg. Co., Inc.
Gastroenterology & Urology · 40d
Cleared Nov 28, 1977
SYRINGE, IRRIGATION, PRE-FILLED
K772134
Kendall Research Center
Gastroenterology & Urology · 14d
Cleared Feb 24, 1977
ANAL/RECTAL SYRINGE
K761229
Ace Orthopedic Manufacturing Co.
Gastroenterology & Urology · 76d
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