510(k) K232005

HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) by Smith & Nephew, Inc. — Product Code MBI

K232005 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)". The FDA issued a decision of Substantially Equivalent on August 4, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.