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 a medical device manufactured by Medi-Tate , Ltd.. It received FDA 510(k) clearance on 2021-06-25 under approval 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. It is manufactured by Medi-Tate , Ltd.. The 510(k) number is K210138.
When was iTind System approved by the FDA?
iTind System received FDA 510(k) clearance on 2021-06-25, under approval number K210138.
What company makes iTind System?
iTind System is manufactured by Medi-Tate , Ltd..
What is the FDA product code for iTind System?
The FDA product code for iTind System is QKA.
Other Devices by Medi-Tate , Ltd.
Related Devices (Code: QKA)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.