Pulse Biosciences, Inc.
Hayward, CA, US
PULSE BIOSCIENCES, INC. appears in FDA device records in Hayward, CA. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Pulse Biosciences, Inc. between 2021 and 2024. The busiest year on record is 2022, with 3. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 2 |
| 2022 | 3 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240782 | CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) | GEI | Substantially Equivalent | |
| K233705 | CellFX Percutaneous Electrode System (SYS3000) | GEI | Substantially Equivalent | |
| K213674 | CellFX System | GEI | Substantially Equivalent | |
| K222075 | CellFX System | GEI | Substantially Equivalent | |
| K221671 | CellFX® System | GEI | Substantially Equivalent | |
| K211444 | CellFX System | GEI | Substantially Equivalent | |
| K203299 | CellFX System | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013686892 | 3013686892 | PULSE BIOSCIENCES, INC. | 3957 Point Eden Way, Hayward, CA 94545 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain