Cleared Special

JMS Harmony A.V. Fistula Needle Set

K151017 · JMS North America Corporation · Gastroenterology & Urology
May 2015
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K151017 is an FDA 510(k) clearance for the JMS Harmony A.V. Fistula Needle Set, 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 May 13, 2015, 27 days after receiving the submission on April 16, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K151017 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2015
Decision Date May 13, 2015
Days to Decision 27 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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