CellFX® System
K-Number: K221671 · 2022-08-01
ApplicantPulse Biosciences, Inc.
Decision Date2022-08-01
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 2022-08-01 under approval number K221671. 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 2022-08-01. It is manufactured by Pulse Biosciences, Inc.. The 510(k) number is K221671.
When was CellFX® System approved by the FDA?
CellFX® System received FDA 510(k) clearance on 2022-08-01, under approval number K221671.
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
Other Devices by Pulse Biosciences, Inc.
Related Devices (Code: GEI)
K161307NICO MyriadNico Corporation
K163190InMode RF SystemInmode MD , Ltd.
K163373PK AIMGyrus Acmi, Inc.
K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL
K162676Voyant Open Fusion DeviceApplied Medical Resources
K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien
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.