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FDA 510(k)

RocaTub Ureteral Catheter

K-Number: K192183 · 2020-04-23

ApplicantPromepal Sam
Decision Date2020-04-23
Product CodeEYB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RocaTub Ureteral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Promepal Sam. It received FDA 510(k) clearance on 2020-04-23 under 510(k) 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. The listed applicant is Promepal Sam. The 510(k) number is K192183.

When did RocaTub Ureteral Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for RocaTub Ureteral Catheter?

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

What is the FDA product code for RocaTub Ureteral Catheter?

The FDA product code for RocaTub Ureteral Catheter is EYB.

Related Devices (Code: EYB)

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.

K191187Dornier MINNOW Ureteral CatheterDornier Medtech America, Inc.K183323UPJ Occlusion Balloon CatheterCook IncorporatedK182695Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral CatheterCook IncorporatedK182122Ureteric CathetersColoplast Corp.K180182Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access CatheterCook IncorporatedK171043Ureteric 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.

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