I-TIND System

Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia

Medi-Tate Ltd.

The following data is part of a De Novo classification by Medi-tate Ltd. with the FDA for I-tind System.

Pre-market Notification Details

DeNovo IDDEN190020
Device Name:I-TIND System
ClassificationTemporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Applicant Medi-Tate Ltd. 14 Hailan Street Or Akiva,  IL 3060000
ContactLihi Liviatan
Product CodeQKA  
CFR Regulation Number876.5510 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
TypeDirect
Date Received2019-04-02
Decision Date2020-02-25
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290015518083 DEN190020 000
07290015518109 DEN190020 000
07290015518086 DEN190020 000
07290015518079 DEN190020 000
07290015518062 DEN190020 000
07290015518192 DEN190020 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.