DeviceClearance

Product code LYU— General, Plastic Surgery

ACTION MEDTEK FACE SHIELD

Classification name
Accessory, Surgical Apparel
Device class
Class 1
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Total cleared
56
First cleared
Most recent

Market context for product code LYU

FDA has cleared 56 devices under product code LYU between 1988 and 2001, filed by 43 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

Top applicants under product code LYU

Recent clearances under product code LYU

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