FDA 510(k)

RocaTub Ureteral Catheter

K-Number: K192183 · 2020-04-23

Decision Date2020-04-23

Product CodeEYB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

RocaTub Ureteral Catheter is a medical device manufactured by Promepal Sam. It received FDA 510(k) clearance on 2020-04-23 under approval number K192183. 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 RocaTub Ureteral Catheter?

RocaTub Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2020-04-23. It is manufactured by Promepal Sam. The 510(k) number is K192183.

When was RocaTub Ureteral Catheter approved by the FDA?

RocaTub Ureteral Catheter received FDA 510(k) clearance on 2020-04-23, under approval number K192183.

What company makes RocaTub Ureteral Catheter?

RocaTub Ureteral Catheter is manufactured by Promepal Sam.

What is the FDA product code for RocaTub Ureteral Catheter?

The FDA product code for RocaTub Ureteral Catheter is EYB.

Related Clinical Trials

NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED NCT06798753 Occlusion Balloon vs. 5FR Ureteral Catheter COMPLETED

Related Devices (Code: EYB)

K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersColoplast Corp. 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

Official Source

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