FDA 510(k)

TYBR Collagen Gel

K-Number: K250109 · 2025-06-06

Decision Date2025-06-06

Product CodeOWY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TYBR Collagen Gel is the device name listed in this FDA 510(k) record. The listed applicant is Tybr Health. It received FDA 510(k) clearance on 2025-06-06 under 510(k) number K250109. 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 TYBR Collagen Gel?

TYBR Collagen Gel is a medical device that received FDA 510(k) clearance on 2025-06-06. The listed applicant is Tybr Health. The 510(k) number is K250109.

When did TYBR Collagen Gel receive FDA 510(k) clearance?

TYBR Collagen Gel received FDA 510(k) clearance on 2025-06-06, under 510(k) number K250109.

Who is the listed applicant for TYBR Collagen Gel?

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

What is the FDA product code for TYBR Collagen Gel?

The FDA product code for TYBR Collagen Gel is OWY.

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.K243843Tendon Protect (50242)Kerecis Limited K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.K220867Tapestry Biointegrative ImplantEmbody, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.