Data / Medical devices / United States / Tybr Health, Inc.
Tybr Health, Inc.: FDA-registered device maker in Houston, TX, United States, 1 510(k) clearance
Tybr Health, Inc. is registered with the FDA (registration 3027383505) in Houston, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027383505
- Address
- 2450 Holcombe Blvd Ste X, Houston, TX, United States, 77021
- Owner or operator
- TYBR Health, Inc. (10093752)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 2, 2025
- Registered through
- 2026
- Brand names listed
- B3 GEL System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical | FTM | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 6, 2025 | K250109 | TYBR Collagen Gel | OWY | Substantially Equivalent | Tybr Health | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- All makers of Mesh, Surgical
Updated June 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.