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FDA 510(k)

iTind System

K-Number: K210138 · 2021-06-25

ApplicantMedi-Tate , Ltd.
Decision Date2021-06-25
Product CodeQKA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

iTind System is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tate , Ltd.. It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K210138. The device is classified under product code QKA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iTind System?

iTind System is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Medi-Tate , Ltd.. The 510(k) number is K210138.

When did iTind System receive FDA 510(k) clearance?

iTind System received FDA 510(k) clearance on 2021-06-25, under 510(k) number K210138.

Who is the listed applicant for iTind System?

The FDA 510(k) record lists Medi-Tate , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iTind System?

The FDA product code for iTind System is QKA.

Related Devices (Code: QKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261342Urocross Expander System (UES-2018-C1)Prodeon Medical, Inc.K253525Urocross Expander System (Model Numbers ES2018 and ES3025)Prodeon Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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