FDA 510(k)

Uroview FD

K-Number: K161019 · 2016-08-17

Decision Date2016-08-17

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Uroview FD is the device name listed in this FDA 510(k) record. The listed applicant is Pausch Medical GmbH. It received FDA 510(k) clearance on 2016-08-17 under 510(k) number K161019. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Uroview FD?

Uroview FD is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Pausch Medical GmbH. The 510(k) number is K161019.

When did Uroview FD receive FDA 510(k) clearance?

Uroview FD received FDA 510(k) clearance on 2016-08-17, under 510(k) number K161019.

Who is the listed applicant for Uroview FD?

The FDA 510(k) record lists Pausch Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uroview FD?

The FDA product code for Uroview FD is JAA.

Other records listing Pausch Medical GmbH 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.

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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.