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FDA 510(k)

NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube

K-Number: K230320 · 2023-10-26

ApplicantMedtronic Xomed, Inc.
Decision Date2023-10-26
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube is a medical device manufactured by Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2023-10-26 under approval number K230320. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube?

NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube is a medical device that received FDA 510(k) clearance on 2023-10-26. It is manufactured by Medtronic Xomed, Inc.. The 510(k) number is K230320.

When was NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube approved by the FDA?

NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube received FDA 510(k) clearance on 2023-10-26, under approval number K230320.

What company makes NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube?

NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube is manufactured by Medtronic Xomed, Inc..

What is the FDA product code for NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube?

The FDA product code for NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube is ETN.

Related Clinical Trials

NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING NCT07578441 VitaSmart HOPE System: Bridge to HOPE Registry ENROLLING_BY_INVITATION NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT06449924 An Endotracheal Tube Inserted to the Level of the Hypopharynx COMPLETED NCT07408154 Direct vs Standard SLT for Glaucoma: A Noninferiority Trial RECRUITING NCT07231653 Home Monitoring Study for Surgical Patients NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Other Devices by Medtronic Xomed, Inc.

K173855Sharpsite AC Rigid Endsocope K200759NIM Vital, Nerve Integrity Monitor K210841NuVent Eustachian Tube Dilation Balloon K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long K231580NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)

View all 7 devices →

Related Devices (Code: ETN)

K152769FREMAP ELECTRODEAd-Tech Medical Instrument Corporation K152505C2 NerveMonitor SystemInomed Medizintechnik GmbH K200886StimSiteAllotrope Medical, Inc. K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeCheckpoint Surgical K212164Mapping Suction ProbeInomed Medizintechnik GmbH K213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongMedtronic Xomed, Inc.

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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