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FDA 510(k)

URO PRO

K-Number: K042457 · 2004-10-25

ApplicantW.O.M. World of Medicine AG
Decision Date2004-10-25
Product CodeLJH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URO PRO is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine AG. It received FDA 510(k) clearance on 2004-10-25 under 510(k) number K042457. The device is classified under product code LJH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URO PRO?

URO PRO is a medical device that received FDA 510(k) clearance on 2004-10-25. The listed applicant is W.O.M. World of Medicine AG. The 510(k) number is K042457.

When did URO PRO receive FDA 510(k) clearance?

URO PRO received FDA 510(k) clearance on 2004-10-25, under 510(k) number K042457.

Who is the listed applicant for URO PRO?

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

What is the FDA product code for URO PRO?

The FDA product code for URO PRO is LJH.

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Related Devices (Code: LJH)

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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