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FDA 510(k)

PUREVUE™ FMS

K-Number: K250795 · 2025-12-05

ApplicantW.O.M. World of Medicine GmbH
Decision Date2025-12-05
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PUREVUE™ FMS is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2025-12-05 under 510(k) 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. The listed applicant is W.O.M. World of Medicine GmbH. The 510(k) number is K250795.

When did PUREVUE™ FMS receive FDA 510(k) clearance?

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

Who is the listed applicant for PUREVUE™ FMS?

The FDA 510(k) record lists W.O.M. World of Medicine GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUREVUE™ FMS?

The FDA product code for PUREVUE™ FMS is HRX.

Other records listing W.O.M. World of Medicine GmbH as applicant

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Related Devices (Code: HRX)

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.

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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.

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