Aevumed FASE Suture Anchor
K-Number: K253040 · 2025-10-21
ApplicantAevumed, Inc.
Decision Date2025-10-21
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Aevumed FASE Suture Anchor is a medical device manufactured by Aevumed, Inc.. It received FDA 510(k) clearance on 2025-10-21 under approval number K253040. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aevumed FASE Suture Anchor?
Aevumed FASE Suture Anchor is a medical device that received FDA 510(k) clearance on 2025-10-21. It is manufactured by Aevumed, Inc.. The 510(k) number is K253040.
When was Aevumed FASE Suture Anchor approved by the FDA?
Aevumed FASE Suture Anchor received FDA 510(k) clearance on 2025-10-21, under approval number K253040.
What company makes Aevumed FASE Suture Anchor?
Aevumed FASE Suture Anchor is manufactured by Aevumed, Inc..
What is the FDA product code for Aevumed FASE Suture Anchor?
The FDA product code for Aevumed FASE Suture Anchor is MBI.
Related PubMed Literature
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.