Redsense and the FDA held a Pre-Submission Meeting in Preparation for the 510(k) Premarket Submission for the Redsense Clamp

Redsense Medical announces that it held a 510(k) Pre-Submission meeting with the United States Food and Drug Administration (FDA) concerning the 510(k) Premarket submission for the Redsense Clamp.

The aim of the meeting was to ensure that there is a common view of the regulatory pathway and documentation needed for the 510(k) Premarket application process.

In the meeting, FDA officials provided constructive and supportive feedback and guidance concerning the regulatory requirements for the Redsense Clamp, which will be utilized in the coming 510(k) filing.

“We are pleased with the progress made thus far and the valuable feedback we have received from the FDA as we prepare to submit the 510(k) Premarket application for the Redsense Clamp.” says Pontus Nobréus, CEO of Redsense Medical AB.