Product code FEX— Gastroenterology, Urology
BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE.
- Classification name
- Instrument, Catheter, Punch
- Device class
- Class 1
- Regulation
- 21 CFR 876.5090
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code FEX
FDA has cleared devices under product code FEX between 1977 and 1991, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1991
- 1977
Top applicants under product code FEX
Recent clearances under product code FEX
Data sourced from openFDA. This site is unofficial and independent of the FDA.