Cleared Special

K251832 - InZone IST Detachment System

Also marketed or referenced as:
IZDS Connecting Cable

K251832 is an FDA 510(k) clearance for InZone IST Detachment System, manufactured by Stryker Neurovascular. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 123-day FDA review.

K251832 · Stryker Neurovascular · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
123d
Days
Class 2
Risk

K251832 is an FDA 510(k) clearance for the InZone IST Detachment System. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on October 17, 2025 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K251832

510(k) Number K251832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 149d · This submission: 123d
Pathway characteristics
Modification to existing cleared device.

HCG Device Classification - Class 2, Special Controls

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HCG Device, Neurovascular Embolization

All 186
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K251832.
Numen™ Helia Coil Embolization System
K260351 · MicroPort NeuroTech (Shanghai) Co., Ltd. · May 2026
Optima Coil System (OptiOne Coil System)
K254221 · Balt USA, LLC · Jan 2026
Target Detachable Coil
K252694 · Stryker Neurovascular · Dec 2025
Optima Coil System (Optima Packing Coil System)
K252700 · Balt USA, LLC · Sep 2025
Numen™ Coil Embolization System
K242154 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Sep 2024
Optima Coil System (OptiBlock Line Extension)
K242582 · Balt USA, LLC · Sep 2024
K251832 · InZone IST Detachment System
Download PDF FDA Summary Stryker Neurovascular