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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 the device name listed in this FDA 510(k) record. The listed applicant is Pulse Biosciences, Inc.. It received FDA 510(k) clearance on 2024-03-08 under 510(k) 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. The listed applicant is Pulse Biosciences, Inc.. The 510(k) number is K233705.

When did CellFX Percutaneous Electrode System (SYS3000) receive FDA 510(k) clearance?

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

Who is the listed applicant for CellFX Percutaneous Electrode System (SYS3000)?

The FDA 510(k) record lists Pulse Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07287176Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode SystemRECRUITING

Other records listing Pulse Biosciences, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240782CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)K213674CellFX SystemK222075CellFX SystemK221671CellFX® SystemK211444CellFX SystemK203299CellFX System

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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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