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FDA 510(k)

COMPASS CT STEREOTACTIC ADAPTATION SYSTEM

K-Number: K862220 · 1986-06-18

ApplicantStereotactic Medical Systems, Inc.
Decision Date1986-06-18
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COMPASS CT STEREOTACTIC ADAPTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stereotactic Medical Systems, Inc.. It received FDA 510(k) clearance on 1986-06-18 under 510(k) number K862220. 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 COMPASS CT STEREOTACTIC ADAPTATION SYSTEM?

COMPASS CT STEREOTACTIC ADAPTATION SYSTEM is a medical device that received FDA 510(k) clearance on 1986-06-18. The listed applicant is Stereotactic Medical Systems, Inc.. The 510(k) number is K862220.

When did COMPASS CT STEREOTACTIC ADAPTATION SYSTEM receive FDA 510(k) clearance?

COMPASS CT STEREOTACTIC ADAPTATION SYSTEM received FDA 510(k) clearance on 1986-06-18, under 510(k) number K862220.

Who is the listed applicant for COMPASS CT STEREOTACTIC ADAPTATION SYSTEM?

The FDA 510(k) record lists Stereotactic Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPASS CT STEREOTACTIC ADAPTATION SYSTEM?

The FDA product code for COMPASS CT STEREOTACTIC ADAPTATION SYSTEM 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 Stereotactic Medical Systems, Inc. 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.

K896156COMPASS(TM) STEREOTACTIC RETRACTOR SYSTEMK884415EP-100 (SERIES)K883653EP-100 INFUSION PUMPK871046COMPASS STEREOTACTIC POSITIONING SYSTEM

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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