SuturePatch Tissue Reinforcement
K-Number: K243480 · 2025-05-29
ApplicantArthrex, Inc.
Decision Date2025-05-29
Product CodeOWX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SuturePatch Tissue Reinforcement is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-05-29 under approval number K243480. The device is classified under product code OWX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SuturePatch Tissue Reinforcement?
SuturePatch Tissue Reinforcement is a medical device that received FDA 510(k) clearance on 2025-05-29. It is manufactured by Arthrex, Inc.. The 510(k) number is K243480.
When was SuturePatch Tissue Reinforcement approved by the FDA?
SuturePatch Tissue Reinforcement received FDA 510(k) clearance on 2025-05-29, under approval number K243480.
What company makes SuturePatch Tissue Reinforcement?
SuturePatch Tissue Reinforcement is manufactured by Arthrex, Inc..
What is the FDA product code for SuturePatch Tissue Reinforcement?
The FDA product code for SuturePatch Tissue Reinforcement is OWX.
Related Clinical Trials
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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.