EYB · Class II · 21 CFR 876.5130

FDA Product Code EYB: Catheter, Ureteral, Gastro-urology

Leading manufacturers include Cook Incorporated, C.R. Bard, Inc. and Coloplast Corp..

28
Total
28
Cleared
150d
Avg days
1988
Since

FDA 510(k) Cleared Catheter, Ureteral, Gastro-urology Devices (Product Code EYB)

28 devices
1–24 of 28
Cleared Apr 23, 2020
RocaTub Ureteral Catheter
K192183
Promepal Sam
Gastroenterology & Urology · 255d
Cleared Sep 18, 2019
Dornier MINNOW Ureteral Catheter
K191187
Dornier Medtech America, Inc.
Gastroenterology & Urology · 138d
Cleared Aug 05, 2019
UPJ Occlusion Balloon Catheter
K183323
Cook Incorporated
Gastroenterology & Urology · 248d
Cleared Jun 17, 2019
Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter
K182695
Cook Incorporated
Gastroenterology & Urology · 263d
Cleared Oct 04, 2018
Ureteric Catheters
K182122
Coloplast Corp.
Gastroenterology & Urology · 59d
Cleared Sep 14, 2018
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
K180182
Cook Incorporated
Gastroenterology & Urology · 234d
Cleared Jan 08, 2014
OCCLUDER OCCLUSION BALLOON CATHETER
K133750
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jan 21, 2010
MEDLINE RED RUBBER URETHRAL CATHETER
K092250
Medline Industries, Inc.
Gastroenterology & Urology · 177d
Cleared Nov 14, 2003
BARD DUAL LUMEN URETERAL CATHETER
K032521
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Apr 27, 1995
BARD FLEXIBLE TIP URETERAL CATHETER
K950300
C.R. Bard, Inc.
Gastroenterology & Urology · 92d
Cleared Jan 03, 1994
MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER
K933020
Boston Scientific Corp
Gastroenterology & Urology · 195d

About Product Code EYB - Regulatory Context