Product code FXW— General, Plastic Surgery
IMPERVIOUS ISOLATION SHOE COVERS
- Classification name
- Shoes, Operating-Room
- Device class
- Class 1
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code FXW
FDA has cleared device under product code FXW, all in 1993, filed by 1 applicant company. 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.
Top applicants under product code FXW
Recent clearances under product code FXW
Data sourced from openFDA. This site is unofficial and independent of the FDA.