510(k) K141084

Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix by Acell, Inc. — Product Code FTM

K141084 is an FDA 510(k) premarket notification submitted by Acell, Inc. for the device "Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix". The FDA issued a decision of Substantially Equivalent on Jun 17, 2015. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Acell, Inc. has at least 10 other 510(k) clearances on record.