Data / Medical devices / United States / Starch Medical Inc.
Starch Medical Inc.: FDA-registered device maker in San Jose, CA, United States, 2 510(k) clearances
Starch Medical Inc. is registered with the FDA (registration 3007215524) in San Jose, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007215524
- Address
- 2150 Ringwood Ave, San Jose, CA, United States, 95131
- Owner or operator
- Starch Medical Inc. (10090488)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 13, 2024
- Registered through
- 2026
- Brand names listed
- RESPONDER Polysaccharide Hemostat
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | 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 |
|---|---|---|---|---|---|---|
| March 15, 2024 | K240454 | RESPONDER® Polysaccharide Hemostat | QSY | Substantially Equivalent | Starch Medical, Inc. | accessdata.fda.gov |
| December 4, 2023 | K220525 | RESPONDER Polysaccharide Hemostat | QSY | Substantially Equivalent | Starch Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 15, 2024. 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.