Data / Medical devices / United States / Tusker Medical Inc.
Tusker Medical Inc.: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance and 1 PMA approval
Tusker Medical Inc. is registered with the FDA (registration 3012130335) in Austin, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated April 23, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3012130335
- Address
- 7000 W. William Cannon Dr. Suite 110, Austin, TX, United States, 78735
- Owner or operator
- Smith & Nephew, Inc. (1020279)
- Roles
- Specification developer
- First device listed
- March 12, 2020
- Registered through
- 2027
- Brand names listed
- Tula Tympanostomy Tube Delivery Device, Tympanostomy Tube Delivery System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Tube, Tympanostomy | ETD | 2 | Specification developer | accessdata.fda.gov |
| Tympanostomy Tube Delivery Product With Drug | QJA | 3 | 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 |
|---|---|---|---|---|---|---|
| April 23, 2026 | K252436 | Tula Tympanostomy Tube Delivery Device | ETD | Substantially Equivalent | Tusker Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 25, 2019 | P190016 | Tula® System | QJA | 11 | July 31, 2026 | accessdata.fda.gov |
Compare with other makers
Updated July 31, 2026. 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.