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FDA 510(k)

AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC

K-Number: K924348 · 1992-11-23

ApplicantAd-Tech Medical Instrument Corp
Decision Date1992-11-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC 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 1992-11-23 under 510(k) number K924348. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC?

AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC is a medical device that received FDA 510(k) clearance on 1992-11-23. The listed applicant is Ad-Tech Medical Instrument Corp. The 510(k) number is K924348.

When did AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC receive FDA 510(k) clearance?

AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC received FDA 510(k) clearance on 1992-11-23, under 510(k) number K924348.

Who is the listed applicant for AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC?

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 AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC?

The FDA product code for AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC is HAW.

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Other records listing Ad-Tech Medical Instrument Corp as applicant

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.

K112094BRAIN BIOPSY NEEDLEK053363DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODESK053358DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODESK041604MACRO-MICRO DEPTH ELECTRODEK990788AD-TECH'S FORAMEN OVALE ELECTRODEK992194CORTICAL MAPPING UNIT, MODEL CMU

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Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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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