Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TYBR Collagen Gel

K-Number: K250109 · 2025-06-06

ApplicantTybr Health
Decision Date2025-06-06
Product CodeOWY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TYBR Collagen Gel is a medical device manufactured by Tybr Health. It received FDA 510(k) clearance on 2025-06-06 under approval 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. It is manufactured by Tybr Health. The 510(k) number is K250109.

When was TYBR Collagen Gel approved by the FDA?

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

What company makes TYBR Collagen Gel?

TYBR Collagen Gel is manufactured by Tybr Health.

What is the FDA product code for TYBR Collagen Gel?

The FDA product code for TYBR Collagen Gel is OWY.

Related Devices (Code: OWY)

K151083BioBridge Collagen MatrixFibralign Corporation K201572TAPESTRY Biointegrative ImplantEmbody, Inc. K212306Tapestry Biointegrative ImplantEmbody, Inc. K220867Tapestry Biointegrative ImplantEmbody, Inc. K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc. K242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.

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.

↑