Data / Medical devices / United States / Single Pass, Inc.
Single Pass, Inc.: FDA-registered device maker in Lake Forest, CA, United States, 1 510(k) clearance
Single Pass, Inc. is registered with the FDA (registration 3025268689) in Lake Forest, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025268689
- Address
- 105 North Pointe Drive Suite B, Lake Forest, CA, United States, 92630
- Owner or operator
- Single Pass, Inc. (10086664)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- December 1, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer, Manufacturer for export | 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 25, 2024 | K232805 | Kronos Electrocautery Device | GEI | Substantially Equivalent | Single Pass, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 25, 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.