Zenflow Spring® Implant and Delivery System
FDA premarket approval P250007 · decided 2025-12-11
Approval details
- PMA number
- P250007
- Trade name
- Zenflow Spring® Implant and Delivery System
- Generic name
- STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
- Applicant
- Zenflow, Inc.
- Date received
- 2025-03-11
- Decision date
- 2025-12-11
- Days to decision
- 275 days
- Decision code
- APPR
- Product code
- MER
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- South San Francisco, CA
- Statement
- The Zenflow Spring Implant and Delivery System is indicated for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths between 25 and 45 mm and prostate sizes between 25 and 80 cc.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Zenflow Spring Scope (K251140) | Zenflow, Inc. | 2025-09-23 |