FDA 510(k)

Ureteric Catheters

K-Number: K182122 · 2018-10-04

Decision Date2018-10-04

Product CodeEYB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Ureteric Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2018-10-04 under 510(k) number K182122. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ureteric Catheters?

Ureteric Catheters is a medical device that received FDA 510(k) clearance on 2018-10-04. The listed applicant is Coloplast Corp.. The 510(k) number is K182122.

When did Ureteric Catheters receive FDA 510(k) clearance?

Ureteric Catheters received FDA 510(k) clearance on 2018-10-04, under 510(k) number K182122.

Who is the listed applicant for Ureteric Catheters?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ureteric Catheters?

The FDA product code for Ureteric Catheters is EYB.

Other records listing Coloplast Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P000006Device, impotence, mechanical/hydraulic PMA P020003Prosthesis, testicular K252140Heylo™ System K251116Luja Coudé K250270Luja Set K242049SureCath Set

View all 42 devices →

Related Devices (Code: EYB)

K192183RocaTub Ureteral CatheterPromepal Sam K191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.K183323UPJ Occlusion Balloon CatheterCook Incorporated K182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook Incorporated K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook Incorporated K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersColoplast Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.