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FDA 510(k)

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

K-Number: K231580 · 2023-08-30

ApplicantMedtronic Xomed, Inc.
Decision Date2023-08-30
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2023-08-30 under 510(k) 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. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K231580.

When did NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) receive FDA 510(k) clearance?

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

Who is the listed applicant for NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)?

The FDA 510(k) record lists Medtronic Xomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Medtronic Xomed, Inc. as applicant

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.

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)K230320NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal TubeK213246NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm LongK210841NuVent Eustachian Tube Dilation BalloonK202623Novapak Nasal Sinus Packing and StentK200759NIM Vital, Nerve Integrity Monitor

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Related Devices (Code: ETN)

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.

K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc.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)Medtronic Xomed, Inc.K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)Inomed Medizintechnik GmbHK233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S.K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLCK232888Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., 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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