iTind System— 510(k) DEN190020

Unknown

Medi-Tate , Ltd.

FDA 510(k) clearance DEN190020 for iTind System, Unknown on 2020-02-25. Applicant: Medi-Tate , Ltd.. Device class: 2.

Clearance details

Applicant: Medi-Tate , Ltd.
Product code: Code QKA
Device class: Class 2
Regulation: 21 CFR 876.5510
Advisory panel: Gastroenterology, Urology
Date received: 2019-04-02
Decision date: 2020-02-25
Decision: Unknown
Clearance type: Direct
Location: Or-Akiva, IL

View on FDA.gov ↗

Recent devices under product code QKA

K261342 — Urocross Expander System (UES-2018-C1)2026-06-22
K253525 — Urocross Expander System (Model Numbers ES2018 and ES3025)2026-03-12
K210138 — iTind System2021-06-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.