510(k) K881224

ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE by Acufex Microsurgical, Inc. — Product Code GAE

K881224 is an FDA 510(k) premarket notification submitted by Acufex Microsurgical, Inc. for the device "ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE". The FDA issued a decision of Substantially Equivalent on June 1, 1988. The device falls under product code GAE (Snare, Surgical), a Class I device regulated under 21 CFR 878.4800. Acufex Microsurgical, Inc. has at least 10 other 510(k) clearances on record.