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FDA 510(k)

STELTHSTATION WIRELESS SURGEON MOUSE

K-Number: K051029 · 2005-06-08

ApplicantMedtronic Surgical Navigation
Decision Date2005-06-08
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STELTHSTATION WIRELESS SURGEON MOUSE 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 2005-06-08 under 510(k) number K051029. 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 STELTHSTATION WIRELESS SURGEON MOUSE?

STELTHSTATION WIRELESS SURGEON MOUSE is a medical device that received FDA 510(k) clearance on 2005-06-08. The listed applicant is Medtronic Surgical Navigation. The 510(k) number is K051029.

When did STELTHSTATION WIRELESS SURGEON MOUSE receive FDA 510(k) clearance?

STELTHSTATION WIRELESS SURGEON MOUSE received FDA 510(k) clearance on 2005-06-08, under 510(k) number K051029.

Who is the listed applicant for STELTHSTATION WIRELESS SURGEON MOUSE?

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 STELTHSTATION WIRELESS SURGEON MOUSE?

The FDA product code for STELTHSTATION WIRELESS SURGEON MOUSE 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.

K001801STEATHSTATION TREATMENT GUIDANCE PLATFORMK001153MODIFICATION 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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