Data / Medical devices / United States / Endofix Medical Technologies
Endofix Medical Technologies: FDA-registered device maker in Plainville, MA, United States, 1 510(k) clearance
Endofix Medical Technologies is registered with the FDA (registration 3031276312) in Plainville, MA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 20, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031276312
- Address
- 111 Washington St. Suite 201i, Plainville, MA, United States, 02762
- Owner or operator
- Endofix Medical Technologies (10094222)
- Roles
- Specification developer
- First device listed
- November 19, 2025
- Registered through
- 2026
- Brand names listed
- EndoFix Tissue Fixation Device, Secure Suture Locking Device
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Endoscopic Tissue Approximation Device | OCW | 2 | Specification developer | accessdata.fda.gov |
| Hemostatic Metal Clip For The Gi Tract | PKL | 2 | Specification developer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | 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 |
|---|---|---|---|---|---|---|
| August 20, 2025 | K251229 | EndoFixTissue Fixation System | FGE | Substantially Equivalent | Softac Medical Technologies | accessdata.fda.gov |
Compare with other makers
- All makers of Hemostatic Metal Clip For The Gi Tract
- All makers of Stents, Drains And Dilators For The Biliary Ducts
- All makers of Endoscopic Tissue Approximation Device
Updated August 20, 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.