FDA 510K, K240782 CellFX Percutaneous Electrode System (SYS3000)

Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number: K240782
Device Name: CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)
Applicant: Pulse Biosciences, Inc.
Regulation Number: 878.4400
Classification Product Code: GEI  
Date Received: 03/21/2024
Decision Date: 08/05/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Type: Traditional

Total Pages: 425
Fully Redacted Pages: 37
Content Pages: 388 (total pages minus fully redacted pages)