meddevicedb.com FDA Device Reference

iTind System

DEN190020 Class II Direct
Decision Date
2020-02-25
Sponsor / Applicant
Medi-Tate , Ltd.

Technical Specification

510(k) Submission ID DEN190020
Product Code QKA
Medical Specialty / Panel Gastroenterology, Urology
Regulation Citation 21 CFR 876.5510
Decision Date 2020-02-25
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

iTind System received FDA 510(k) clearance under submission number DEN190020, sponsored by Medi-Tate , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-02-25.

Classification & Regulation

This clearance is catalogued under FDA product code QKA and 21 CFR 876.5510, within the Gastroenterology, Urology review panel as a Class II device.