Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STEALTHSTATION TREATMENT GUIDANCE PLATFORM

K-Number: K003201 · 2000-12-12

ApplicantMedtronic Surgical Navigation Technologies
Decision Date2000-12-12
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STEALTHSTATION TREATMENT GUIDANCE PLATFORM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Surgical Navigation Technologies. It received FDA 510(k) clearance on 2000-12-12 under 510(k) number K003201. 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 STEALTHSTATION TREATMENT GUIDANCE PLATFORM?

STEALTHSTATION TREATMENT GUIDANCE PLATFORM is a medical device that received FDA 510(k) clearance on 2000-12-12. The listed applicant is Medtronic Surgical Navigation Technologies. The 510(k) number is K003201.

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

STEALTHSTATION TREATMENT GUIDANCE PLATFORM received FDA 510(k) clearance on 2000-12-12, under 510(k) number K003201.

Who is the listed applicant for STEALTHSTATION TREATMENT GUIDANCE PLATFORM?

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

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

The FDA product code for STEALTHSTATION 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medtronic Surgical Navigation Technologies 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.

K050438STEALTHSTATION SYSTEM UPDATEK043088MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULEK030552IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEMK030106STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULEK022126CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEMK021980HIP MODULE FOR THE STEALTHSTATION SYSTEM

View all 12 devices →

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.

↑