Dilator, Urethral, Mechanical
FDA product code FAH · Class II (moderate risk) · 21 CFR 876.5520 · Gastroenterology, Urology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933957 | Dilating Urethral SoundFAH · Traditional | Cook Urological, Inc. | 11/17/1993SE |
| K902370 | Modified Prostatic Urethroplasty Balloon CatheterFAH · Traditional | Boston Scientific Corp | 08/17/1990SE |
| K902124 | Dowd CatheterFAH · Traditional | Boston Scientific Corp | 08/09/1990SE |
| K831384 | Coaxial Balloon Urethral DilatorFAH · Traditional | Thomas J. Fogarty, M.D. | 07/26/1983SE |