FDA 510(k)

NeuroLine Disposable Cranial Perforator with Hudson end

Numéro K : K213228 · 2022-06-20

DemandeurEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.

Date de décision2022-06-20

Code produitHBF

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

NeuroLine Disposable Cranial Perforator with Hudson end is the device name listed in this FDA 510(k) record. The listed applicant is Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.. It received FDA 510(k) clearance on 2022-06-20 under 510(k) number K213228. The device is classified under product code HBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the NeuroLine Disposable Cranial Perforator with Hudson end?

NeuroLine Disposable Cranial Perforator with Hudson end is a medical device that received FDA 510(k) clearance on 2022-06-20. The listed applicant is Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.. The 510(k) number is K213228.

When did NeuroLine Disposable Cranial Perforator with Hudson end receive FDA 510(k) clearance?

NeuroLine Disposable Cranial Perforator with Hudson end received FDA 510(k) clearance on 2022-06-20, under 510(k) number K213228.

Who is the listed applicant for NeuroLine Disposable Cranial Perforator with Hudson end?

The FDA 510(k) record lists Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroLine Disposable Cranial Perforator with Hudson end?

The FDA product code for NeuroLine Disposable Cranial Perforator with Hudson end is HBF.

Essais cliniques associés

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Dispositifs connexes (Code : HBF)

K254177Disposable Sterile Skull Drill (LZ)Guizhou Zirui Technology Co., Ltd.K231403evoDrill Cranial PerforatorEvonos GmbH & Co. KG K183581Codman Disposable PerforatorsIntegra Lifesciences Corp.

Source officielle

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