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FDA 510(k)

TELIGEN System Peripheral Motor Nerve Stimulation Indications

K-Number: K223438 · 2023-02-10

ApplicantMedos International SARL
Decision Date2023-02-10
Product CodePDQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TELIGEN System Peripheral Motor Nerve Stimulation Indications is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K223438. The device is classified under product code PDQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TELIGEN System Peripheral Motor Nerve Stimulation Indications?

TELIGEN System Peripheral Motor Nerve Stimulation Indications is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Medos International SARL. The 510(k) number is K223438.

When did TELIGEN System Peripheral Motor Nerve Stimulation Indications receive FDA 510(k) clearance?

TELIGEN System Peripheral Motor Nerve Stimulation Indications received FDA 510(k) clearance on 2023-02-10, under 510(k) number K223438.

Who is the listed applicant for TELIGEN System Peripheral Motor Nerve Stimulation Indications?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELIGEN System Peripheral Motor Nerve Stimulation Indications?

The FDA product code for TELIGEN System Peripheral Motor Nerve Stimulation Indications is PDQ.

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Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 26394389Regulation of Peripheral Nerve Stimulation Technology.Progress in neurological surgery (2015)

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Related Devices (Code: PDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260992iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)NeuralytixK253580Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)Tedan Surgical InnovationsK243636Neuralytix iD3 System (NTX-9001)Neuralytix, LLCK221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.K220160PediGuard ThreadedSpineguard S.A.K203684Neurosign V4 Intraoperative Nerve MonitorMagstim Company, Ltd.

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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