Cleared Traditional

K222533 - Target Tetra Detachable Coils

K222533 is the FDA 510(k) clearance for Target Tetra Detachable Coils by Stryker Neurovascular. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K222533 · Stryker Neurovascular · Neurology device
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Dec 2022
Decision
114d
Days
Class 2
Risk

K222533 is an FDA 510(k) clearance for the Target Tetra Detachable Coils. 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 14, 2022 after a review of 114 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

Submission Details

510(k) Number K222533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2022
Decision Date December 14, 2022
Days to Decision 114 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
34d faster than avg
Panel avg: 148d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K222533.
Numen Coil Embolization System
K232955 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Jan 2024
Axium Detachable Coil
K233420 · Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular · Nov 2023
Penumbra LP Coil System
K230284 · Penumbra, Inc. · Oct 2023
Optima Coil System
K223386 · Balt USA, LLC · Dec 2022
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
K220040 · Medos International SARL · Jul 2022
InZone Detachment System
K212455 · Stryker Neurovascular · Nov 2021