Cleared Traditional

K180651 - Uroview FD II
(FDA 510(k) Clearance)

K180651 · Pausch Medical GmbH · Radiology

Apr 2018

Decision

30d

Days

Class 2

Risk

K180651 is an FDA 510(k) clearance for the Uroview FD II. 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 April 12, 2018, 30 days after receiving the submission on March 13, 2018.

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

Submission Details

510(k) Number	K180651 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2018
Decision Date	April 12, 2018
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF