FDA 510(k)

I.T.S. PRS Phoenix II

K-Number: K260054 · 2026-04-24

Decision Date2026-04-24

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

I.T.S. PRS Phoenix II is a medical device manufactured by I.T.S. GmbH. It received FDA 510(k) clearance on 2026-04-24 under approval number K260054. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.T.S. PRS Phoenix II?

I.T.S. PRS Phoenix II is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by I.T.S. GmbH. The 510(k) number is K260054.

When was I.T.S. PRS Phoenix II approved by the FDA?

I.T.S. PRS Phoenix II received FDA 510(k) clearance on 2026-04-24, under approval number K260054.

What company makes I.T.S. PRS Phoenix II?

I.T.S. PRS Phoenix II is manufactured by I.T.S. GmbH.

What is the FDA product code for I.T.S. PRS Phoenix II?

The FDA product code for I.T.S. PRS Phoenix II is HRS.

Other Devices by I.T.S. GmbH

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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.