Product code FCH— Gastroenterology, Urology
MANAN UBK ULTRASONIC GUIDED BIOPSY KIT
- Classification name
- Tray, Biopsy, Without Biopsy Instruments
- Device class
- Class 1
- Regulation
- 21 CFR 876.4730
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code FCH
FDA has cleared devices under product code FCH between 1985 and 1988, 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
- 1988
- 1985
Top applicants under product code FCH
Recent clearances under product code FCH
Data sourced from openFDA. This site is unofficial and independent of the FDA.