FDA 510(k)

NeuroLine Disposable Cranial Perforator with Hudson end

N.º K: K213228 · 2022-06-20

SolicitanteEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.

Fecha de decisión2022-06-20

Código de productoHBF

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: HBF)

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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.