TYBR Collagen Gel
FDA 510(k) K250109 · Tybr Health
510(k) numberK250109
Submission
- Device name
- TYBR Collagen Gel
- Applicant
- Tybr Health
Houston, TX, US - Received
- January 16, 2025
- Decision date
- June 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWY – Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists in tendon repair.
Other 510(k)s with product code OWY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251690 | Arthrex SpeedFLEX ImplantOWY · Traditional | Arthrex, Inc. | 09/30/2025SE |
| K252647 | Tapestry Biointegrative ImplantOWY · Special | Embody, Inc. | 09/19/2025SE |
| K243843 | Tendon Protect (50242)OWY · Traditional | Kerecis Limited | 06/04/2025SE |
| K242631 | REGENETEN Bioinductive ImplantOWY · Traditional | Smith & Nephew Inc., Endoscopy Div. | 11/26/2024SE |
| K222501 | Regeneten Bioinductive ImplantOWY · Traditional | Smith and Nephew, Inc. | 05/11/2023SE |
| K220867 | Tapestry Biointegrative ImplantOWY · Traditional | Embody, Inc. | 05/23/2022SE |
| K212306 | Tapestry Biointegrative ImplantOWY · Traditional | Embody, Inc. | 11/02/2021SE |
| K201572 | TAPESTRY Biointegrative ImplantOWY · Traditional | Embody, Inc. | 10/19/2020SE |
| K151083 | BioBridge Collagen MatrixOWY · Traditional | Fibralign Corporation | 01/08/2016SE |
| K140300 | Collagen Tendon Sheet-Ddi (Cts-Ddi)OWY · Traditional | Rotation Medical, Inc. | 03/26/2014SE |
Questions and answers
When was TYBR Collagen Gel cleared by the FDA?
TYBR Collagen Gel (K250109) received a 510(k) decision of Substantially Equivalent on June 6, 2025, 141 days after the submission was received.
What is the product code of K250109?
The FDA product code is OWY – Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon, a Class II (moderate risk) device regulated under 21 CFR 878.3300.