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510(k) Data Aggregation
K Number
K250109Device Name
TYBR Collagen Gel
Manufacturer
TYBR Health
Date Cleared
2025-06-06
(141 days)
Product Code
OWY, FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
TYBR Health
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TYBR Collagen Gel is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.
Device Description
TYBR Collagen Gel is a naturally-derived collagenous semi-permeable barrier device that conforms to the application site and degrades within 30 days. The TYBR Collagen Gel includes a blue color additive to aid with visualization. The applicator provides controlled delivery of the collagen gel to support uniform coverage at the desired location.
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