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FDA 510(k)

CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)

K-Number: K240782 · 2024-08-05

ApplicantPulse Biosciences, Inc.
Decision Date2024-08-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) is a medical device manufactured by Pulse Biosciences, Inc.. It received FDA 510(k) clearance on 2024-08-05 under approval number K240782. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)?

CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) is a medical device that received FDA 510(k) clearance on 2024-08-05. It is manufactured by Pulse Biosciences, Inc.. The 510(k) number is K240782.

When was CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) approved by the FDA?

CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) received FDA 510(k) clearance on 2024-08-05, under approval number K240782.

What company makes CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)?

CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) is manufactured by Pulse Biosciences, Inc..

What is the FDA product code for CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)?

The FDA product code for CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) is GEI.

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Other Devices by Pulse Biosciences, Inc.

K211444CellFX System K203299CellFX System K213674CellFX System K222075CellFX System K221671CellFX® System K233705CellFX Percutaneous Electrode System (SYS3000)

View all 7 devices →

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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