DeviceClearance

Product code FYB— General, Plastic Surgery

DENTAL BIB

Classification name
Gown, Patient
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Total cleared
6
First cleared
Most recent

Market context for product code FYB

FDA has cleared 6 devices under product code FYB between 1977 and 1991, filed by 6 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

Top applicants under product code FYB

Recent clearances under product code FYB

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