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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2025-05-29 under 510(k) 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. The listed applicant is Arthrex, Inc.. The 510(k) number is K243480.

When did SuturePatch Tissue Reinforcement receive FDA 510(k) clearance?

SuturePatch Tissue Reinforcement received FDA 510(k) clearance on 2025-05-29, under 510(k) number K243480.

Who is the listed applicant for SuturePatch Tissue Reinforcement?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SuturePatch Tissue Reinforcement?

The FDA product code for SuturePatch Tissue Reinforcement is OWX.

Other records listing Arthrex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: OWX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AGK250997Integrity™ ImplantAnika Therapeutics, Inc.K241219FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)ZuriMED Technologies AGK223538Integrity ImplantAnika Therapeutics, Inc.

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.

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