Cleared Special

Target Detachable Coils

K242243 · Stryker Neurovscular · Neurology

Aug 2024

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K242243 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 Neurovscular (Freemont, US). The FDA issued a Cleared decision on August 29, 2024, 29 days after receiving the submission on July 31, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number	K242243 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2024
Decision Date	August 29, 2024
Days to Decision	29 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF