510(k) K952535

ACUFEX ENDOBUTTON TAPE by Acufex Microsurgical, Inc. — Product Code GAT

K952535 is an FDA 510(k) premarket notification submitted by Acufex Microsurgical, Inc. for the device "ACUFEX ENDOBUTTON TAPE". The FDA issued a decision of SN on February 8, 1996. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Acufex Microsurgical, Inc. has at least 10 other 510(k) clearances on record.