Cleared Special

ELISIO-H HEMODIALYZER

K131381 · Nipro Medical Corporation · Gastroenterology & Urology

Dec 2013

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K131381 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 (Suwanee, US). The FDA issued a Cleared decision on December 19, 2013, 219 days after receiving the submission on May 14, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K131381 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2013
Decision Date	December 19, 2013
Days to Decision	219 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