Cleared Special

ELISIO-H HEMODIALYZER

K140191 · Nipro Medical Corporation · Gastroenterology & Urology

Apr 2014

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K140191 is an FDA 510(k) clearance for the ELISIO-H HEMODIALYZER, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on April 14, 2014, 77 days after receiving the submission on January 27, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K140191 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2014
Decision Date	April 14, 2014
Days to Decision	77 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5860