FDA 510(k)

Cranial Drill Bits and Accessories

N.º K: K170442 · 2017-09-07

SolicitanteAd-Tech Medical Instrument Corporation

Fecha de decisión2017-09-07

Código de productoHBE

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cranial Drill Bits and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K170442. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cranial Drill Bits and Accessories?

Cranial Drill Bits and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K170442.

When did Cranial Drill Bits and Accessories receive FDA 510(k) clearance?

Cranial Drill Bits and Accessories received FDA 510(k) clearance on 2017-09-07, under 510(k) number K170442.

Who is the listed applicant for Cranial Drill Bits and Accessories?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cranial Drill Bits and Accessories?

The FDA product code for Cranial Drill Bits and Accessories is HBE.

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Otros registros que enlistan a Ad-Tech Medical Instrument Corporation como solicitante

K223276Bujones Anchor como Accesorios de Electrodos de Profundidad K223269Spencer Probe Depth Electrodes K191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode K181544Anchor Bolt (como accesorio de Electrodos de Profundidad)K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes K152769FREMAP ELECTRODE

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Dispositivos relacionados (Código: HBE)

Fuente oficial

Ver en la base de datos de la FDA →

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