Cleared Traditional

Target Detachable Coil

K252694 · Stryker Neurovascular · Neurology
Dec 2025
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K252694 is an FDA 510(k) clearance for the Target Detachable Coil, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on December 11, 2025, 107 days after receiving the submission on August 26, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K252694 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2025
Decision Date December 11, 2025
Days to Decision 107 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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