K240782

CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)

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. CA · US
Product code
GEI — Electrosurgical, Cutting & Coagulation & Accessories
Decision date
2024-08-05
Date received
2024-03-21
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
510(k) Summary (official FDA PDF): K240782.pdf
Official FDA record: K240782
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.