FAH
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dilator, Urethral, Mechanical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5520
- Medical specialty
- Gastroenterology, Urology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DILATING URETHRAL SOUND (K933957) | Cook Urological, Inc. | 1993-11-17 |
| MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER (K902370) | Boston Scientific Corp | 1990-08-17 |
| DOWD CATHETER (K902124) | Boston Scientific Corp | 1990-08-09 |
| COAXIAL BALLOON URETHRAL DILATOR (K831384) | Thomas J. Fogarty, M.D. | 1983-07-26 |
Track FAH automatically
Every clearance here is in the API, with alerts when new ones post.