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FDA 510(k)

DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES

K-Number: K053358 · 2006-05-25

ApplicantAd-Tech Medical Instrument Corp
Decision Date2006-05-25
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corp. It received FDA 510(k) clearance on 2006-05-25 under 510(k) number K053358. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES?

DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES is a medical device that received FDA 510(k) clearance on 2006-05-25. The listed applicant is Ad-Tech Medical Instrument Corp. The 510(k) number is K053358.

When did DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES receive FDA 510(k) clearance?

DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES received FDA 510(k) clearance on 2006-05-25, under 510(k) number K053358.

Who is the listed applicant for DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES?

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

What is the FDA product code for DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES?

The FDA product code for DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES is GZL.

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K112094BRAIN BIOPSY NEEDLEK053363DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODESK041604MACRO-MICRO DEPTH ELECTRODEK990788AD-TECH'S FORAMEN OVALE ELECTRODEK992194CORTICAL MAPPING UNIT, MODEL CMUK973454AD-TECH'S SPINAL ELECTRODE

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Related Devices (Code: GZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253970Wovyn Depth ElectrodeSensomedical Labs, Ltd.K250363Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); DeptBeijing Sinovation Medical Technology Co., Ltd.K250601Neuro Omega System; NeuroSmart SystemAlpha Omega Engineering , Ltd.K223269Spencer Probe Depth ElectrodesAd-Tech Medical Instrument CorporationK223276Anchor Bolts as Accessories to Depth ElectrodesAd-Tech Medical Instrument CorporationK213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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