FDA 510(k)

Visserie d'ancrage comme accessoires pour les électrodes de profondeur

Numéro K : K223276 · 2023-05-18

DemandeurAd-Tech Medical Instrument Corporation

Date de décision2023-05-18

Code produitGZL

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Anchor Bolts as Accessories to Depth Electrodes 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 2023-05-18 under 510(k) number K223276. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Anchor Bolts as Accessories to Depth Electrodes?

Anchor Bolts as Accessories to Depth Electrodes is a medical device that received FDA 510(k) clearance on 2023-05-18. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K223276.

When did Anchor Bolts as Accessories to Depth Electrodes receive FDA 510(k) clearance?

Anchor Bolts as Accessories to Depth Electrodes received FDA 510(k) clearance on 2023-05-18, under 510(k) number K223276.

Who is the listed applicant for Anchor Bolts as Accessories to Depth Electrodes?

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 Anchor Bolts as Accessories to Depth Electrodes?

The FDA product code for Anchor Bolts as Accessories to Depth Electrodes is GZL.

Essais cliniques associés

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Autres dossiers indiquant Ad-Tech Medical Instrument Corporation en tant que demandeur

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 (comme accessoire des Electrodes de Profondeur)K170442Cranial Drill Bits and Accessories K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes K152769FREMAP ELECTRODE

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Dispositifs connexes (Code : GZL)

Source officielle

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