FDA 510(k)

PUREVUE FMS

K-Number: K250795 · 2025-12-05

Decision Date2025-12-05

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PUREVUE FMS is a medical device manufactured by W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2025-12-05 under approval number K250795. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUREVUE FMS?

PUREVUE FMS is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by W.O.M. World of Medicine GmbH. The 510(k) number is K250795.

When was PUREVUE FMS approved by the FDA?

PUREVUE FMS received FDA 510(k) clearance on 2025-12-05, under approval number K250795.

What company makes PUREVUE FMS?

PUREVUE FMS is manufactured by W.O.M. World of Medicine GmbH.

What is the FDA product code for PUREVUE FMS?

The FDA product code for PUREVUE FMS is HRX.

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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.