Cleared Traditional

K161019 - Uroview FD
(FDA 510(k) Clearance)

K161019 · Pausch Medical GmbH · Radiology

Aug 2016

Decision

127d

Days

Class 2

Risk

K161019 is an FDA 510(k) clearance for the Uroview FD. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA).

Submitted by Pausch Medical GmbH (Erlangen, DE). The FDA issued a Cleared decision on August 17, 2016, 127 days after receiving the submission on April 12, 2016.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K161019 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2016
Decision Date	August 17, 2016
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF