510(k) K980103

ACUMED SUTURE ANCHOR by Acu Med, Inc. — Product Code MBI

K980103 is an FDA 510(k) premarket notification submitted by Acu Med, Inc. for the device "ACUMED SUTURE ANCHOR". The FDA issued a decision of Substantially Equivalent on March 16, 1998. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Acu Med, Inc. has at least 10 other 510(k) clearances on record.