510(k) K231093

AlphaVent Suture Anchors by Stryker Endoscopy — Product Code MBI

K231093 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "AlphaVent Suture Anchors". The FDA issued a decision of Substantially Equivalent on August 30, 2023. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Stryker Endoscopy has at least 10 other 510(k) clearances on record.