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FDA 510(k)

SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION

K-Number: K010542 · 2001-05-08

ApplicantSurgical Navigation Specialists, Inc.
Decision Date2001-05-08
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Navigation Specialists, Inc.. It received FDA 510(k) clearance on 2001-05-08 under 510(k) number K010542. 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 SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION?

SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION is a medical device that received FDA 510(k) clearance on 2001-05-08. The listed applicant is Surgical Navigation Specialists, Inc.. The 510(k) number is K010542.

When did SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION receive FDA 510(k) clearance?

SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION received FDA 510(k) clearance on 2001-05-08, under 510(k) number K010542.

Who is the listed applicant for SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION?

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

What is the FDA product code for SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION?

The FDA product code for SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION 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 Surgical Navigation Specialists, 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.

K994421SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATIONK992457SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION

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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