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FDA 510(k)

NaviNetics Reusable Stereotactic System (NN1000)

K-Number: K231392 · 2023-07-14

ApplicantNavinetics, Inc.
Decision Date2023-07-14
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NaviNetics Reusable Stereotactic System (NN1000) is a medical device manufactured by Navinetics, Inc.. It received FDA 510(k) clearance on 2023-07-14 under approval number K231392. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NaviNetics Reusable Stereotactic System (NN1000)?

NaviNetics Reusable Stereotactic System (NN1000) is a medical device that received FDA 510(k) clearance on 2023-07-14. It is manufactured by Navinetics, Inc.. The 510(k) number is K231392.

When was NaviNetics Reusable Stereotactic System (NN1000) approved by the FDA?

NaviNetics Reusable Stereotactic System (NN1000) received FDA 510(k) clearance on 2023-07-14, under approval number K231392.

What company makes NaviNetics Reusable Stereotactic System (NN1000)?

NaviNetics Reusable Stereotactic System (NN1000) is manufactured by Navinetics, Inc..

What is the FDA product code for NaviNetics Reusable Stereotactic System (NN1000)?

The FDA product code for NaviNetics Reusable Stereotactic System (NN1000) is HAW.

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Official Source

View on FDA Database →

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

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