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FDA 510(k)

THE ROBOGUIDE

K-Number: K961849 · 1996-08-21

ApplicantShai Syg Motion and Innovations, Ltd.
Decision Date1996-08-21
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE ROBOGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Shai Syg Motion and Innovations, Ltd.. It received FDA 510(k) clearance on 1996-08-21 under 510(k) number K961849. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ROBOGUIDE?

THE ROBOGUIDE is a medical device that received FDA 510(k) clearance on 1996-08-21. The listed applicant is Shai Syg Motion and Innovations, Ltd.. The 510(k) number is K961849.

When did THE ROBOGUIDE receive FDA 510(k) clearance?

THE ROBOGUIDE received FDA 510(k) clearance on 1996-08-21, under 510(k) number K961849.

Who is the listed applicant for THE ROBOGUIDE?

The FDA 510(k) record lists Shai Syg Motion and Innovations, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE ROBOGUIDE?

The FDA product code for THE ROBOGUIDE is IZH.

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 Shai Syg Motion and Innovations, Ltd. 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.

K964460THE ROBOLITE

Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, Inc.

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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