Cleared Traditional

K140562 - WIJAY EZ-VOID EXTERNAL CATHETER VALVE
(FDA 510(k) Clearance)

K140562 · Leomed, LLC · Gastroenterology & Urology
Jun 2014
Decision
103d
Days
Class 2
Risk

K140562 is an FDA 510(k) clearance for the WIJAY EZ-VOID EXTERNAL CATHETER VALVE. This device is classified as a Accessories, Catheter, G-u (Class II — Special Controls, product code KNY).

Submitted by Leomed, LLC (Houston, US). The FDA issued a Cleared decision on June 16, 2014, 103 days after receiving the submission on March 5, 2014.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K140562 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2014
Decision Date June 16, 2014
Days to Decision 103 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KNY — Accessories, Catheter, G-u
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130