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FDA 510(k)

STEATHSTATION TREATMENT GUIDANCE PLATFORM

K-Number: K001801 · 2000-06-30

ApplicantMedtronic Surgical Navigation
Decision Date2000-06-30
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STEATHSTATION TREATMENT GUIDANCE PLATFORM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Surgical Navigation. It received FDA 510(k) clearance on 2000-06-30 under 510(k) number K001801. 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 STEATHSTATION TREATMENT GUIDANCE PLATFORM?

STEATHSTATION TREATMENT GUIDANCE PLATFORM is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Medtronic Surgical Navigation. The 510(k) number is K001801.

When did STEATHSTATION TREATMENT GUIDANCE PLATFORM receive FDA 510(k) clearance?

STEATHSTATION TREATMENT GUIDANCE PLATFORM received FDA 510(k) clearance on 2000-06-30, under 510(k) number K001801.

Who is the listed applicant for STEATHSTATION TREATMENT GUIDANCE PLATFORM?

The FDA 510(k) record lists Medtronic Surgical Navigation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEATHSTATION TREATMENT GUIDANCE PLATFORM?

The FDA product code for STEATHSTATION TREATMENT GUIDANCE PLATFORM is HAW.

Related Clinical Trials

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.

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Other records listing Medtronic Surgical Navigation 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.

K051029STELTHSTATION WIRELESS SURGEON MOUSEK001153MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM

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

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

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