Class Class II

Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575)

K242575 2025-05-23 Traditional
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Description

Stereotaxic Guiding Surgical Devices, NaoTrac S by Brain Navi Biotechnology Co., Ltd., an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242575
Clearance Date2025-05-23
Clearance TypeTraditional
Product CodeHAW
Regulation Number882.4560

Categories

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Predicate lineage for K242575

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Stereotaxic Guiding Surgical Devices, NaoTrac S (K242575) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K182417ROSA ONE Brain ApplicationMedtech S.A2019

Trace the full predicate network for K242575

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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