# Pulse Biosciences, Inc.

- Location (FDA's records): Hayward, CA
- FDA decisions: 7 (2021–2024): 7 510(k) clearances
- Product codes: GEI (7)
- 510(k) review time since 2016: median 107 days, against 146 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 5 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.: 1 (https://510kreport.com/company/surgnova-healthcare-technologies-zhejiang)
- Invasix, Ltd.: 1 (https://510kreport.com/company/invasix)

## Its most-cited devices
- K211444: CellFX System (2021), cited by 3
- K233705: CellFX Percutaneous Electrode System (SYS3000) (2024), cited by 1
- K203299: CellFX System (2021), cited by 1

## Recent decisions
- K240782: CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) (Aug 5, 2024)
- K233705: CellFX Percutaneous Electrode System (SYS3000) (Mar 8, 2024)
- K213674: CellFX System (Sep 22, 2022)
- K222075: CellFX System (Sep 2, 2022)
- K221671: CellFX® System (Aug 1, 2022)
- K211444: CellFX System (Aug 25, 2021)
- K203299: CellFX System (Feb 2, 2021)

Source page: https://510kreport.com/company/pulse-biosciences