Data / Medical devices / United States / DuraStat
DuraStat: FDA-registered device maker in Austin, TX, United States, 2 510(k) clearances
DuraStat is registered with the FDA (registration 3015489699) in Austin, TX, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 8, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015489699
- Address
- 1101 E 6th St Unit B, Austin, TX, United States, 78702
- Owner or operator
- DuraStat LLC (10059251)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 14, 2018
- Registered through
- 2026
- Brand names listed
- DuraStat, TissueStat
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Holder, Needle; Orthopedic | HXK | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 8, 2018 | K173335 | Gazelle PTFE and Suture Delivery Device | NBY | Substantially Equivalent | Dura Tap, LLC | accessdata.fda.gov |
| April 6, 2005 | K043539 | DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES | GAM | Substantially Equivalent | Demetech Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Holder, Needle; Orthopedic
- All makers of Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Updated February 8, 2018. 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.