510(k) K233893

AlphaVent Knotless SP PEEK Anchor by Stryker Endoscopy — Product Code MBI

K233893 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "AlphaVent Knotless SP PEEK Anchor". The FDA issued a decision of Substantially Equivalent on January 25, 2024. 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.