Name: Predicase
Price: 199 USD

K-number	K252572
Device name	Prodeon Urethral Sheath System
Applicant	Prodeon Medical, Inc.
Product code	FED
Device class	Class II
Decision date	Oct 7, 2025
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Prodeon Urethral Sheath System

Everything you need for a 510(k) submission. Nothing you don't.