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FDA 510(k)

Prodeon Urethral Sheath System

K-Number: K252572 · 2025-10-07

ApplicantProdeon Medical, Inc.
Decision Date2025-10-07
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Prodeon Urethral Sheath System is a medical device manufactured by Prodeon Medical, Inc.. It received FDA 510(k) clearance on 2025-10-07 under approval number K252572. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prodeon Urethral Sheath System?

Prodeon Urethral Sheath System is a medical device that received FDA 510(k) clearance on 2025-10-07. It is manufactured by Prodeon Medical, Inc.. The 510(k) number is K252572.

When was Prodeon Urethral Sheath System approved by the FDA?

Prodeon Urethral Sheath System received FDA 510(k) clearance on 2025-10-07, under approval number K252572.

What company makes Prodeon Urethral Sheath System?

Prodeon Urethral Sheath System is manufactured by Prodeon Medical, Inc..

What is the FDA product code for Prodeon Urethral Sheath System?

The FDA product code for Prodeon Urethral Sheath System is FED.

Related Clinical Trials

NCT04829994 Post-Market Clinical Follow-Up onTVT EXACT® Continence System ACTIVE_NOT_RECRUITING NCT04829357 Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System RECRUITING NCT05186740 ProVee Urethral Expander System IDE Study (ProVIDE) ACTIVE_NOT_RECRUITING NCT07505940 Bilateral Comparison of Unilateral Sacral Neuromodulation Test Stimulation in the Treatment of Neurogenic Bladder NOT_YET_RECRUITING

Other Devices by Prodeon Medical, Inc.

K253525Urocross Expander System (Model Numbers ES2018 and ES3025)

Related Devices (Code: FED)

K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd. K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. K160846AmplifEYEMedivators, Inc. K160861Proxis Ureteral Access SheathC.R. Bard, Inc. K151084Well Lead Ureteral Access SheathWell Lead Medical Co., Ltd. K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated

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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