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FDA 510(k)

UROVANTAGE

K-Number: K053279 · 2005-12-22

ApplicantPck Electronic Industry & Trade Co., Ltd.
Decision Date2005-12-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UROVANTAGE is the device name listed in this FDA 510(k) record. The listed applicant is Pck Electronic Industry & Trade Co., Ltd.. It received FDA 510(k) clearance on 2005-12-22 under 510(k) number K053279. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROVANTAGE?

UROVANTAGE is a medical device that received FDA 510(k) clearance on 2005-12-22. The listed applicant is Pck Electronic Industry & Trade Co., Ltd.. The 510(k) number is K053279.

When did UROVANTAGE receive FDA 510(k) clearance?

UROVANTAGE received FDA 510(k) clearance on 2005-12-22, under 510(k) number K053279.

Who is the listed applicant for UROVANTAGE?

The FDA 510(k) record lists Pck Electronic Industry & Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROVANTAGE?

The FDA product code for UROVANTAGE is OWB.

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Other records listing Pck Electronic Industry & Trade Co., Ltd. as applicant

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.

K061350LITHODIAMOND ULTRAK011106STONELITH, MODEL V5K011311UROLOGIC

Related Devices (Code: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.

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.

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