iTind System— 510(k) K210138

Substantially Equivalent

Medi-Tate , Ltd.

FDA 510(k) clearance K210138 for iTind System, Substantially Equivalent on 2021-06-25. 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: 2021-01-19
Decision date: 2021-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hadera, IL

Download summary PDF 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
DEN190020 — iTind System2020-02-25

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