DeviceClearance

Product code GAX— General, Plastic Surgery

TOURNIQUET

Classification name
Tourniquet, Nonpneumatic
Device class
Class 1
Regulation
21 CFR 878.5900
Advisory panel
General, Plastic Surgery
Total cleared
20
First cleared
Most recent

Market context for product code GAX

FDA has cleared 20 devices under product code GAX between 1978 and 1993, filed by 19 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 GAX

Recent clearances under product code GAX

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