Tendon Protect (50242)
K-Number: K243843 · 2025-06-04
ApplicantKerecis Limited
Decision Date2025-06-04
Product CodeOWY
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Tendon Protect (50242) is a medical device manufactured by Kerecis Limited. It received FDA 510(k) clearance on 2025-06-04 under approval number K243843. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tendon Protect (50242)?
Tendon Protect (50242) is a medical device that received FDA 510(k) clearance on 2025-06-04. It is manufactured by Kerecis Limited. The 510(k) number is K243843.
When was Tendon Protect (50242) approved by the FDA?
Tendon Protect (50242) received FDA 510(k) clearance on 2025-06-04, under approval number K243843.
What company makes Tendon Protect (50242)?
Tendon Protect (50242) is manufactured by Kerecis Limited.
What is the FDA product code for Tendon Protect (50242)?
The FDA product code for Tendon Protect (50242) is OWY.
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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.