Cleared Traditional

MiniMed Quick-serter

K160860 · Medtronic Minimed · General Hospital
Sep 2016
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K160860 is an FDA 510(k) clearance for the MiniMed Quick-serter, a Introducer, Syringe Needle (Class II — Special Controls, product code KZH), submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on September 22, 2016, 177 days after receiving the submission on March 29, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6920.

Submission Details

510(k) Number K160860 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2016
Decision Date September 22, 2016
Days to Decision 177 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZH — Introducer, Syringe Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6920