Product code FBW— Gastroenterology, Urology

LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE

Classification name
Filiform And Filiform Follower
Device class
Class 1
Regulation
21 CFR 876.5520
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

Market context for product code FBW

FDA has cleared 1 device under product code FBW, all in 1991, 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 FBW

Recent clearances under product code FBW

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