DeviceClearance

Product code FRL— General Hospital

BACILLUS PUMILUS

Classification name
Fiber, Medical, Absorbent
Device class
Class 1
Regulation
21 CFR 880.5300
Advisory panel
General Hospital
Total cleared
19
First cleared
Most recent

Market context for product code FRL

FDA has cleared 19 devices under product code FRL between 1977 and 2013, filed by 15 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 FRL

Recent clearances under product code FRL

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