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FDA 510(k)

CellFX Percutaneous Electrode System (SYS3000)

K-Number: K233705 · 2024-03-08

ApplicantPulse Biosciences, Inc.
Decision Date2024-03-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CellFX Percutaneous Electrode System (SYS3000) is a medical device manufactured by Pulse Biosciences, Inc.. It received FDA 510(k) clearance on 2024-03-08 under approval number K233705. 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 System (SYS3000) is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by Pulse Biosciences, Inc.. The 510(k) number is K233705.

When was CellFX Percutaneous Electrode System (SYS3000) approved by the FDA?

CellFX Percutaneous Electrode System (SYS3000) received FDA 510(k) clearance on 2024-03-08, under approval number K233705.

What company makes CellFX Percutaneous Electrode System (SYS3000)?

CellFX Percutaneous Electrode System (SYS3000) is manufactured by Pulse Biosciences, Inc..

What is the FDA product code for CellFX Percutaneous Electrode System (SYS3000)?

The FDA product code for CellFX Percutaneous Electrode System (SYS3000) is GEI.

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Other Devices by Pulse Biosciences, Inc.

K211444CellFX System K203299CellFX System K213674CellFX System K222075CellFX System K221671CellFX® System K240782CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)

View all 7 devices →

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Official Source

View on FDA Database →

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

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