Data / Medical devices / United States / Pulse Biosciences, Inc.
Pulse Biosciences, Inc.: FDA-registered device maker in Hayward, CA, United States, 7 510(k) clearances
Pulse Biosciences, Inc. is registered with the FDA (registration 3013686892) in Hayward, CA, United States. It lists 1 device type. The FDA files 7 510(k) clearances under its listings, the newest dated August 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013686892
- Address
- 3957 Point Eden Way, Hayward, CA, United States, 94545
- Owner or operator
- Pulse Biosciences, Inc. (10080487)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 4, 2021
- Registered through
- 2026
- Brand names listed
- CellFX System, nPulse Vybrance Percutaneous Electrode System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer | 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 5, 2024 | K240782 | CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) | GEI | Substantially Equivalent | Pulse Biosciences, Inc. | accessdata.fda.gov |
| March 8, 2024 | K233705 | CellFX Percutaneous Electrode System (SYS3000) | GEI | Substantially Equivalent | Pulse Biosciences, Inc. | accessdata.fda.gov |
| September 22, 2022 | K213674 | CellFX System | GEI | Substantially Equivalent | Pulse Biosciences, Inc. | accessdata.fda.gov |
| September 2, 2022 | K222075 | CellFX System | GEI | Substantially Equivalent | Pulse Biosciences, Inc. | accessdata.fda.gov |
| August 1, 2022 | K221671 | CellFX® System | GEI | Substantially Equivalent | Pulse Biosciences, Inc. | accessdata.fda.gov |
| August 25, 2021 | K211444 | CellFX System | GEI | Substantially Equivalent | Pulse Biosciences, Inc. | accessdata.fda.gov |
| February 2, 2021 | K203299 | CellFX System | GEI | Substantially Equivalent | Pulse Biosciences, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 5, 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.