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)

MICROTARGETING DRIVE SYSTEM

K-Number: K003776 · 2001-02-23

ApplicantFHC, Inc.
Decision Date2001-02-23
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MICROTARGETING DRIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is FHC, Inc.. It received FDA 510(k) clearance on 2001-02-23 under 510(k) number K003776. 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 MICROTARGETING DRIVE SYSTEM?

MICROTARGETING DRIVE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-02-23. The listed applicant is FHC, Inc.. The 510(k) number is K003776.

When did MICROTARGETING DRIVE SYSTEM receive FDA 510(k) clearance?

MICROTARGETING DRIVE SYSTEM received FDA 510(k) clearance on 2001-02-23, under 510(k) number K003776.

Who is the listed applicant for MICROTARGETING DRIVE SYSTEM?

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

What is the FDA product code for MICROTARGETING DRIVE SYSTEM?

The FDA product code for MICROTARGETING DRIVE 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 FHC, 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.

K231141STarFix Designer Software C0265K200169VFS1 Bipolar Electrosurgical GeneratorK183123microTargeting Guideline 4000 5.0 SystemK121950MICROTARGETING XL STAR DRIVE SYSTEMK092192WAYPOINT STEREOTACTIC SYSTEMK092562MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS

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.

↑