FDA 510(k)

NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)

K-Number: K231580 · 2023-08-30

Decision Date2023-08-30

Product CodeETN

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) is a medical device manufactured by Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2023-08-30 under approval number K231580. 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 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)?

NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) is a medical device that received FDA 510(k) clearance on 2023-08-30. It is manufactured by Medtronic Xomed, Inc.. The 510(k) number is K231580.

When was NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) approved by the FDA?

NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) received FDA 510(k) clearance on 2023-08-30, under approval number K231580.

What company makes NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)?

NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) is manufactured by Medtronic Xomed, Inc..

What is the FDA product code for NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)?

The FDA product code for NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) is ETN.

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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 K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube 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)

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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.