Cleared Traditional

Target Tetra Detachable Coils

K222533 · Stryker Neurovascular · Neurology
Dec 2022
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K222533 is an FDA 510(k) clearance for the Target Tetra Detachable Coils, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on December 14, 2022, 114 days after receiving the submission on August 22, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K222533 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2022
Decision Date December 14, 2022
Days to Decision 114 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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