Cleared Traditional

Spartan eCoil System (K180653) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180653 · Spartan Micro, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
266d
Days
Class 2
Risk

K180653 is an FDA 510(k) clearance for the Spartan eCoil System. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Spartan Micro, Inc. (Fremont, US). The FDA issued a Cleared decision on December 4, 2018 after a review of 266 days - an extended review cycle.

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 Spartan Micro, Inc. devices

Submission Details

510(k) Number K180653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2018
Decision Date December 04, 2018
Days to Decision 266 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
118d slower than avg
Panel avg: 148d · This submission: 266d
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 Consultant

Ambriel Associates, Inc.
Vikki M. O'Connor

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HCG Device, Neurovascular Embolization

All 47
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K180653.
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K172390 · Blockade Medical, LLC (D.B.A. Balt Usa) · Feb 2018