DeviceClearance

Product code MVM— Immunology

AESKULISA TTG A AND AESKULISA TTG G

Classification name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
40
First cleared
Most recent

Market context for product code MVM

FDA has cleared 40 devices under product code MVM between 1998 and 2021, filed by 18 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 MVM

Recent clearances under product code MVM

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