FDA 510(k)

Xtreme-Loop

K-Number: K191053 · 2019-07-17

Decision Date2019-07-17

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Xtreme-Loop is a medical device manufactured by Xiros, Ltd.. It received FDA 510(k) clearance on 2019-07-17 under approval number K191053. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xtreme-Loop?

Xtreme-Loop is a medical device that received FDA 510(k) clearance on 2019-07-17. It is manufactured by Xiros, Ltd.. The 510(k) number is K191053.

When was Xtreme-Loop approved by the FDA?

Xtreme-Loop received FDA 510(k) clearance on 2019-07-17, under approval number K191053.

What company makes Xtreme-Loop?

Xtreme-Loop is manufactured by Xiros, Ltd..

What is the FDA product code for Xtreme-Loop?

The FDA product code for Xtreme-Loop is MBI.

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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.