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

Name: FDA 510(k) clearance K140562
Creator: U.S. Food and Drug Administration
Published: 2014-06-16

Substantially Equivalent

Leomed, LLC

FDA 510(k) clearance K140562 for WIJAY EZ-VOID EXTERNAL CATHETER VALVE, Substantially Equivalent on 2014-06-16. Applicant: Leomed, LLC. Device class: 2.

Clearance details

Applicant: Leomed, LLC
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2014-03-05
Decision date: 2014-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNY

view all

K260919 — Transurethral Catheter Safety Valve (TUCSV) (80050)2026-08-05
K182144 — Bi-Flex Evo2018-09-07
K162356 — Vesair Cystoscopic Sheath2017-03-02
K140441 — BI-FLEX URETERAL ACCESS SHEATH2014-06-17
K141252 — GUARDIAN URETHRAL SHEATH2014-06-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.