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FDA 510(k)

Ureteric Catheters

K-Number: K182122 · 2018-10-04

ApplicantColoplast Corp.
Decision Date2018-10-04
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ureteric Catheters is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2018-10-04 under approval 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. It is manufactured by Coloplast Corp.. The 510(k) number is K182122.

When was Ureteric Catheters approved by the FDA?

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

What company makes Ureteric Catheters?

Ureteric Catheters is manufactured by Coloplast Corp..

What is the FDA product code for Ureteric Catheters?

The FDA product code for Ureteric Catheters is EYB.

Related Clinical Trials

NCT06815120 A Novel Ureteric Stent in Kidney Stone Patients and Oncology Patients Compared to a Conventional JJ Stent RECRUITING

Other Devices by Coloplast Corp.

K161672SpeediCath Flex Coude K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTS K170531Ureteral Dilators and Percutaneous Nephrostomy Dilators K182831SabreLine and SabreGuard Laser Fibers

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Related Devices (Code: EYB)

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

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.

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