FDA 510(k), K233705, CellFX Percutaneous Electrode System (SYS3000)

Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number: K233705
Device Name: CellFX Percutaneous Electrode System (SYS3000)
Applicant: Pulse Biosciences, Inc.
Regulation Number: 878.4400
Classification Product Code: GEI
Date Received: 11/20/2023
Decision Date: 03/08/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery

Total number of pages: 6,046
Fully redacted pages: 5,075
Content pages: 971