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FDA 510(k)

Transurethral Catheter Safety Valve (TUCSV) (80050)

K-Number: K260919 · 2026-08-05

ApplicantClass Medical , Ltd.
Decision Date2026-08-05
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Transurethral Catheter Safety Valve (TUCSV) (80050) is the device name listed in this FDA 510(k) record. The listed applicant is Class Medical , Ltd.. It received FDA 510(k) clearance on 2026-08-05 under 510(k) number K260919. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transurethral Catheter Safety Valve (TUCSV) (80050)?

Transurethral Catheter Safety Valve (TUCSV) (80050) is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is Class Medical , Ltd.. The 510(k) number is K260919.

When did Transurethral Catheter Safety Valve (TUCSV) (80050) receive FDA 510(k) clearance?

Transurethral Catheter Safety Valve (TUCSV) (80050) received FDA 510(k) clearance on 2026-08-05, under 510(k) number K260919.

Who is the listed applicant for Transurethral Catheter Safety Valve (TUCSV) (80050)?

The FDA 510(k) record lists Class Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transurethral Catheter Safety Valve (TUCSV) (80050)?

The FDA product code for Transurethral Catheter Safety Valve (TUCSV) (80050) is KNY.

Related Devices (Code: KNY)

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.

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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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