Chrysalis Intelligence · Sponsors · Prodeon Medical, Inc.

Prodeon Medical, Inc.

Sunnyvale, CA, US · 3 510(k) clearances

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Total clearances

3

2025-10-07 → 2026-06-22

Last 12 months

3

Product codes

2

Most recent

2026-06-22

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
QKA	Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia	Class II	Gastroenterology, Urology	2	2026-06-22
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Class II	Gastroenterology, Urology	1	2025-10-07

Filings

All 510(k) clearances (3)

Date	K-number	Device	Code	Class	Specialty
2026-06-22	K261342	Urocross Expander System (UES-2018-C1)	QKA	Class II	Gastroenterology, Urology
2026-03-12	K253525	Urocross Expander System (Model Numbers ES2018 and ES3025)	QKA	Class II	Gastroenterology, Urology
2025-10-07	K252572	Prodeon Urethral Sheath System	FED	Class II	Gastroenterology, Urology