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FDA 510(k)

NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long

K-Number: K213246 · 2022-03-21

ApplicantMedtronic Xomed, Inc.
Decision Date2022-03-21
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long 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 2022-03-21 under 510(k) number K213246. 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 Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long?

NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long is a medical device that received FDA 510(k) clearance on 2022-03-21. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K213246.

When did NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long receive FDA 510(k) clearance?

NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long received FDA 510(k) clearance on 2022-03-21, under 510(k) number K213246.

Who is the listed applicant for NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long?

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 Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long?

The FDA product code for NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long 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 TubeK231580NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)K210841NuVent 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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