Wijay Ez-Void External Catheter Valve

FDA 510(k) K140562 · Leomed, LLC

Substantially Equivalent

510(k) numberK140562

Submission

Device name
Wijay Ez-Void External Catheter Valve
Applicant
Leomed, LLC
Houston, TX, US
Received
March 5, 2014
Decision date
June 16, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KNY – Accessories, Catheter, G-U
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

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Questions and answers

When was Wijay Ez-Void External Catheter Valve cleared by the FDA?

Wijay Ez-Void External Catheter Valve (K140562) received a 510(k) decision of Substantially Equivalent on June 16, 2014, 103 days after the submission was received.

What is the product code of K140562?

The FDA product code is KNY – Accessories, Catheter, G-U, a Class II (moderate risk) device regulated under 21 CFR 876.5130.