Pulse Biosciences, Inc. announced the filing of a premarket notification 510(k) to the U.S. Food and Drug Administration (FDA) for its novel CellFX nsPFA percutaneous electrode. The Company?s percutaneous electrode is an image-guided needle designed to harness CellFX nsPFA energy to deliver precise and complete nonthermal ablation of cellular tissue without damage to noncellular structures. The percutaneous electrode is designed for non-cardiac applications.

Pursuant to Section 510(k), once the application has been accepted, the FDA will conduct its substantive review and may request additional information from the Company based on that review. FDA guidance suggests the goal is to complete 510(k) substantive review within 90 calendar days, not including time required by the Company to respond to additional information requests. The time required to respond to any such requests will depend on the nature of the request.