DeviceClearance

Product code FXP— General, Plastic Surgery

SHOE COVERS

Classification name
Cover, Shoe, Operating-Room
Device class
Class 1
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Total cleared
36
First cleared
Most recent

Market context for product code FXP

FDA has cleared 36 devices under product code FXP between 1976 and 1998, filed by 29 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

last 15 years

Top applicants under product code FXP

Recent clearances under product code FXP

Data sourced from openFDA. This site is unofficial and independent of the FDA.