Product code FES— Gastroenterology, Urology
MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
- Classification name
- Recorder, External, Pressure, Amplifier & Transducer
- Device class
- Class 2
- Regulation
- 21 CFR 876.1725
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code FES
FDA has cleared devices under product code FES between 1980 and 1989, filed by 2 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
- 1989
- 1980
Top applicants under product code FES
Recent clearances under product code FES
Data sourced from openFDA. This site is unofficial and independent of the FDA.