Cleared Special

JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)

K142564 · JMS North America Corporation · Gastroenterology & Urology
Dec 2014
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K142564 is an FDA 510(k) clearance for the JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4), a Needle, Fistula (Class II — Special Controls, product code FIE), submitted by JMS North America Corporation (Hayward, US). The FDA issued a Cleared decision on December 23, 2014, 103 days after receiving the submission on September 11, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K142564 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2014
Decision Date December 23, 2014
Days to Decision 103 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FIE — Needle, Fistula
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5540

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