Product code FAH— Gastroenterology, Urology
COAXIAL BALLOON URETHRAL DILATOR
- Classification name
- Dilator, Urethral, Mechanical
- Device class
- Class 2
- Regulation
- 21 CFR 876.5520
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code FAH
FDA has cleared devices under product code FAH between 1983 and 1993, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1993
- 1990
- 1983
Top applicants under product code FAH
Recent clearances under product code FAH
Data sourced from openFDA. This site is unofficial and independent of the FDA.