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

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 Mar 02, 1994
LI VASECTOMY
K932465
Femcare , Ltd.
Gastroenterology & Urology · 285d
Cleared Jul 02, 1993
VASOVASOSTOMY SET
K921546
Cook Urological, Inc.
Gastroenterology & Urology · 457d
Cleared May 12, 1993
VESITEC SUTURE PASSER
K931181
Vesitec Medical, Inc.
Gastroenterology & Urology · 64d
Cleared Oct 05, 1992
DDV LIGATOR
K921304
North American Medical, Inc.
Gastroenterology & Urology · 208d
Cleared Sep 23, 1992
NO-SCALPEL VASCETOMY INSTRUMENTS
K922971
Pilling Co.
Gastroenterology & Urology · 96d
Cleared Sep 14, 1992
BENDEREV PROTECT-A-PASS NEEDLE
K921228
Eimark Labs, Inc.
Gastroenterology & Urology · 185d
Cleared Aug 07, 1992
VAS DILATOR
K922192
Cook Urological, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 28, 1989
GRASPING FORCEPS
K896058
Annex Medical, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 23, 1989
MARLOW ANAL SPECULUM
K891352
Simpson/Basye, Inc.
Gastroenterology & Urology · 105d
Cleared Jan 27, 1989
MICROSURGICAL CYSTOTOME
K890218
Kinetic Medical Products
Gastroenterology & Urology · 9d
Cleared Oct 14, 1987
STOMACH EVACULATOR - EWALD STYLE
K864963
Medovations, Inc.
Gastroenterology & Urology · 296d
Cleared Nov 04, 1986
MARTIN MEDICAL PRO-SCOPE ANOSCOPE
K863273
Martin Medical
Gastroenterology & Urology · 71d
Cleared Aug 07, 1985
EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA
K852014
Effner and Spreine Co.
Gastroenterology & Urology · 90d
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

About Product Code KOA - Regulatory Context