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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Kerecis Limited. It received FDA 510(k) clearance on 2025-06-04 under 510(k) 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. The listed applicant is Kerecis Limited. The 510(k) number is K243843.

When did Tendon Protect (50242) receive FDA 510(k) clearance?

Tendon Protect (50242) received FDA 510(k) clearance on 2025-06-04, under 510(k) number K243843.

Who is the listed applicant for Tendon Protect (50242)?

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

What is the FDA product code for Tendon Protect (50242)?

The FDA product code for Tendon Protect (50242) is OWY.

Other records listing Kerecis Limited 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.

K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusK251844Kerecis SurgiBind (50241)K241080Kerecis Parvus (50207)K213904Kerecis OralK213231Kerecis SiliconeK202430Kerecis Reconstruct

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Related Devices (Code: OWY)

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.

K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.K252647Tapestry Biointegrative ImplantEmbody, Inc.K250109TYBR Collagen GelTybr HealthK242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.K220867Tapestry Biointegrative ImplantEmbody, 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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