Class Class II

TELIGEN System Peripheral Motor Nerve Stimulation Indications (K223438)

K223438 2023-02-10 Traditional
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Description

TELIGEN System Peripheral Motor Nerve Stimulation Indications by Medos International SARL, an FDA 510(k) cleared ear, nose, throat device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK223438
Clearance Date2023-02-10
Clearance TypeTraditional
Product CodePDQ
Regulation Number874.1820

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Predicate lineage for K223438

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. TELIGEN System Peripheral Motor Nerve Stimulation Indications (K223438) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K223108TELIGEN System Navigation Ready Indications (TELIGEN Access...Medos International SARL2023
K173134SENTIO MMG Pedicle Access NeedlesMedos International SARL2018

Trace the full predicate network for K223438

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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