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FDA 510(k)

CellFX System

K-Number: K211444 · 2021-08-25

ApplicantPulse Biosciences, Inc.
Decision Date2021-08-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CellFX System is a medical device manufactured by Pulse Biosciences, Inc.. It received FDA 510(k) clearance on 2021-08-25 under approval number K211444. 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 System?

CellFX System is a medical device that received FDA 510(k) clearance on 2021-08-25. It is manufactured by Pulse Biosciences, Inc.. The 510(k) number is K211444.

When was CellFX System approved by the FDA?

CellFX System received FDA 510(k) clearance on 2021-08-25, under approval number K211444.

What company makes CellFX System?

CellFX System is manufactured by Pulse Biosciences, Inc..

What is the FDA product code for CellFX System?

The FDA product code for CellFX System is GEI.

Related Clinical Trials

NCT07018596 NS-PFA Catheter Ablation of Paroxysmal Atrial Fibrillation With the Pulse Biosciences CellFX System RECRUITING NCT06696170 CellFX® Nanosecond Pulsed Field Ablation (PFA) 360 Catheter Ablation System for Treatment of Atrial Fibrillation RECRUITING

Other Devices by Pulse Biosciences, Inc.

K203299CellFX System K213674CellFX System K222075CellFX System K221671CellFX® System K240782CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018) K233705CellFX Percutaneous Electrode System (SYS3000)

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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