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MOTUS GI Medical Technologies Ltd.: FDA-registered device maker in Tirat Carmel Haifa, Israel, 2 510(k) clearances

MOTUS GI Medical Technologies Ltd. is registered with the FDA (registration 3011816755) in Tirat Carmel Haifa, Israel. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 20, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3011816755
Address
22 Keren Ha'yesod st., Tirat Carmel Haifa, Israel, 3902638
Owner or operator
MOTUS GI Medical Technologies Ltd (10053317)
Roles
Complaint file establishment, Specification developer
First device listed
June 28, 2019
Registered through
2026
Brand names listed
Endoscopy Cart, Pure-Vu EVS System, Pure-Vu EVS Waste Bag

Devices it lists

DeviceProduct codeClassRoleSource
Bottle, Collection, VacuumKDQ2Complaint file establishment, Specification developeraccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Complaint file establishment, Specification developeraccessdata.fda.gov
Gastroscope And Accessories, Flexible/RigidFDS2Complaint file establishment, Specification developeraccessdata.fda.gov
Stand, InfusionFOX1Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 20, 2023K232922Pure-Vu EVS SystemFDFSubstantially EquivalentMotus GI Medical Technologies , Ltd.accessdata.fda.gov
February 10, 2022K220007Pure-Vu EVS SystemFDFSubstantially EquivalentMotus GI Medical Technologies , Ltd.accessdata.fda.gov

Compare with other makers

Updated October 20, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.