Cleared Special

InZone IST Detachment System; IZDS Connecting Cable

K251832 · Stryker Neurovascular · Neurology
Oct 2025
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K251832 is an FDA 510(k) clearance for the InZone IST Detachment System; IZDS Connecting Cable, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Stryker Neurovascular (Freemont, US). The FDA issued a Cleared decision on October 17, 2025, 123 days after receiving the submission on June 16, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K251832 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2025
Decision Date October 17, 2025
Days to Decision 123 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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