510(k) K261342
K261342 is an FDA 510(k) premarket notification submitted by Prodeon Medical, Inc. for the device "Urocross Expander System (UES-2018-C1)". The FDA issued a decision of Substantially Equivalent on June 22, 2026. The device falls under product code QKA (Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia), a Class II device regulated under 21 CFR 876.5510. Prodeon Medical, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2026
- Date Received
- April 23, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
- Device Class
- Class II
- Regulation Number
- 876.5510
- Review Panel
- GU
- Submission Type
A system intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.