Data / Medical devices / United States / Cresen Inc
Cresen Inc: FDA-registered device maker in Pleasanton, CA, United States, 2 510(k) clearances
Cresen Inc is registered with the FDA (registration 3030176940) in Pleasanton, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030176940
- Address
- 6200 Stoneridge Mall Rd Fl 3, Pleasanton, CA, United States, 94588
- Owner or operator
- CRESEN Inc (10089823)
- Roles
- Complaint file establishment
- First device listed
- January 10, 2024
- Registered through
- 2026
- Brand names listed
- Duoblade
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment | 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 11, 2025 | K252211 | Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH) | GEI | Substantially Equivalent | Cnc Technologies | accessdata.fda.gov |
| February 3, 2023 | K220996 | Duoblade | GEI | Substantially Equivalent | Cnc Technologies | accessdata.fda.gov |
Compare with other makers
Updated August 11, 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.