PowerKnot High Strength Sutures
K-Number: K252225 · 2025-09-12
ApplicantMedacta International S.A.
Decision Date2025-09-12
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
PowerKnot High Strength Sutures is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-09-12 under approval number K252225. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PowerKnot High Strength Sutures?
PowerKnot High Strength Sutures is a medical device that received FDA 510(k) clearance on 2025-09-12. It is manufactured by Medacta International S.A.. The 510(k) number is K252225.
When was PowerKnot High Strength Sutures approved by the FDA?
PowerKnot High Strength Sutures received FDA 510(k) clearance on 2025-09-12, under approval number K252225.
What company makes PowerKnot High Strength Sutures?
PowerKnot High Strength Sutures is manufactured by Medacta International S.A..
What is the FDA product code for PowerKnot High Strength Sutures?
The FDA product code for PowerKnot High Strength Sutures is GAT.
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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.