Cleared Special

Target Detachable Coils

K161429 · Stryker Neurovascular · Neurology
Jun 2016
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K161429 is an FDA 510(k) clearance for the Target Detachable Coils, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on June 22, 2016, 30 days after receiving the submission on May 23, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K161429 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2016
Decision Date June 22, 2016
Days to Decision 30 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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