DeviceClearance

Product code FIB— Gastroenterology, Urology

TRANSDUCER PROTECTOR

Classification name
Protector, Transducer, Dialysis
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
35
First cleared
Most recent

Market context for product code FIB

FDA has cleared 35 devices under product code FIB between 1981 and 2024, filed by 26 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code FIB

Recent clearances under product code FIB

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