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FDA 510(k)

Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters

K-Number: K171043 · 2017-12-21

ApplicantColoplast Corp.
Decision Date2017-12-21
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2017-12-21 under approval number K171043. 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, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters?

Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters is a medical device that received FDA 510(k) clearance on 2017-12-21. It is manufactured by Coloplast Corp.. The 510(k) number is K171043.

When was Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters approved by the FDA?

Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters received FDA 510(k) clearance on 2017-12-21, under approval number K171043.

What company makes Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters?

Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters is manufactured by Coloplast Corp..

What is the FDA product code for Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters?

The FDA product code for Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated 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

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Related Devices (Code: EYB)

K182122Ureteric 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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