Class Class II

Prodeon Urethral Sheath System (K252572)

K252572 2025-10-07 Traditional
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Description

Prodeon Urethral Sheath System by Prodeon Medical, Inc., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252572
Clearance Date2025-10-07
Clearance TypeTraditional
Product CodeFED
Regulation Number876.1500

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