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

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