FDA 510(k)

DuraFuse Clip and Applier System

K-Number: K213813 · 2022-07-22

Decision Date2022-07-22

Product CodeFZP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DuraFuse Clip and Applier System is a medical device manufactured by Neuramedica, Inc.. It received FDA 510(k) clearance on 2022-07-22 under approval number K213813. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DuraFuse Clip and Applier System?

DuraFuse Clip and Applier System is a medical device that received FDA 510(k) clearance on 2022-07-22. It is manufactured by Neuramedica, Inc.. The 510(k) number is K213813.

When was DuraFuse Clip and Applier System approved by the FDA?

DuraFuse Clip and Applier System received FDA 510(k) clearance on 2022-07-22, under approval number K213813.

What company makes DuraFuse Clip and Applier System?

DuraFuse Clip and Applier System is manufactured by Neuramedica, Inc..

What is the FDA product code for DuraFuse Clip and Applier System?

The FDA product code for DuraFuse Clip and Applier System is FZP.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.