Ureteric Catheters— 510(k) K182122

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K182122 for Ureteric Catheters, Substantially Equivalent on 2018-10-04. Applicant: Coloplast Corp.. Device class: 2.

Clearance details

Applicant: Coloplast Corp.
Product code: Code EYB
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2018-08-06
Decision date: 2018-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EYB

K192183 — RocaTub Ureteral Catheter2020-04-23
K191187 — Dornier MINNOW Ureteral Catheter2019-09-18
K183323 — UPJ Occlusion Balloon Catheter2019-08-05
K182695 — Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter2019-06-17
K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter2018-09-14

More clearances from Coloplast Corp.

Data sourced from openFDA. This site is unofficial and independent of the FDA.