Cleared Traditional

InZone Detachment System

K212455 · Stryker Neurovascular · Neurology
Nov 2021
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K212455 is an FDA 510(k) clearance for the InZone Detachment System, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on November 16, 2021, 103 days after receiving the submission on August 5, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K212455 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2021
Decision Date November 16, 2021
Days to Decision 103 days
Submission Type Traditional
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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