UPJ Occlusion Balloon Catheter

FDA 510(k) K183323 · Cook Incorporated

Unknown

510(k) numberK183323

Submission

Device name
UPJ Occlusion Balloon Catheter
Applicant
Cook Incorporated
Bloomington, IN, US
Received
November 30, 2018
Decision date
August 5, 2019
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EYB – Catheter, Ureteral, Gastro-Urology
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

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Questions and answers

When was UPJ Occlusion Balloon Catheter cleared by the FDA?

UPJ Occlusion Balloon Catheter (K183323) received a 510(k) decision of Unknown on August 5, 2019, 248 days after the submission was received.

What is the product code of K183323?

The FDA product code is EYB – Catheter, Ureteral, Gastro-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.5130.