Cleared Traditional

K252694 - Target Detachable Coil

K252694 is an FDA 510(k) clearance for Target Detachable Coil, manufactured by Stryker Neurovascular. The device is a Class 2 Neurology device with product code HCG cleared through the Traditional 510(k) pathway after a 107-day FDA review.

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

K252694 is an FDA 510(k) clearance for the Target Detachable Coil. 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 December 11, 2025 after a review of 107 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Neurovascular devices

FDA 510(k) Submission Details - K252694

510(k) Number K252694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 148d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 169
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K252694.
Target Xtra Detachable Coil
K261772 · Stryker Neurovscular · Jun 2026
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
InZone IST Detachment System
K251832 · Stryker Neurovascular · Oct 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