Uroview FD II
FDA 510(k) K180651 · Pausch Medical GmbH
510(k) numberK180651
Submission
- Device name
- Uroview FD II
- Applicant
- Pausch Medical GmbH
Erlangen, DE - Received
- March 13, 2018
- Decision date
- April 12, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Uroview FD II cleared by the FDA?
Uroview FD II (K180651) received a 510(k) decision of Substantially Equivalent on April 12, 2018, 30 days after the submission was received.
What is the product code of K180651?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.