FAH — Dilator, Urethral, Mechanical Class II
FDA product code FAH covers "Dilator, Urethral, Mechanical", a Class II medical device regulated under 21 CFR 876.5520. Submissions are reviewed by the Gastroenterology, Urology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FAH
- Device Class
- Class II
- Regulation Number
- 876.5520
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K933957 | cook urological | DILATING URETHRAL SOUND | November 17, 1993 |
| K902370 | boston scientific | MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER | August 17, 1990 |
| K902124 | boston scientific | DOWD CATHETER | August 9, 1990 |
| K831384 | thomas j. fogarty, m.d | COAXIAL BALLOON URETHRAL DILATOR | July 26, 1983 |