Cleared Special

HydroCoil Embolic System (HES)

K161367 · MicroVention, Inc. · Neurology
Aug 2016
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K161367 is an FDA 510(k) clearance for the HydroCoil Embolic System (HES), a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on August 31, 2016, 106 days after receiving the submission on May 17, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K161367 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2016
Decision Date August 31, 2016
Days to Decision 106 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCG — Device, Neurovascular Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5950

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