DeviceClearance

Product code FYA— General, Plastic Surgery

Surgical Gown

Classification name
Gown, Surgical
Device class
Class 2
Regulation
21 CFR 878.4040
Advisory panel
General, Plastic Surgery
Total cleared
298
First cleared
Most recent

Market context for product code FYA

FDA has cleared 298 devices under product code FYA between 1976 and 2026, filed by 177 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 FYA

Recent clearances under product code FYA

1–100 of 298

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