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510(k) K210138

Device
ITind System
Applicant
Medi-Tate Ltd.
510(k) number
K210138
Product code
QKA  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-25
Date received
2021-01-19
Regulation
876.5510
Classification name
Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lihi Liviatan
Address
17 Hauman St. Hadera IL 3850169 3850169

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QKA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253525Urocross Expander System (Model Numbers ES2018 and ES3025)Prodeon Medical, Inc.2026-03-12
DEN190020iTind SystemMedi-Tate , Ltd.2020-02-25

Legacy Summary#

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FDA Review#

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