FDA 510(k)

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

Número K: K231580 · 2023-08-30

Data da decisão2023-08-30

Código do produtoETN

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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