Cleared Special

Optima Coil System (K223386) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K223386 · Balt USA, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
29d
Days
Class 2
Risk

K223386 is an FDA 510(k) clearance for the Optima Coil System. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on December 6, 2022 after a review of 29 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Balt USA, LLC devices

Submission Details

510(k) Number K223386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2022
Decision Date December 06, 2022
Days to Decision 29 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
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 47
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K223386.
Axium Detachable Coil
K233420 · Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular · Nov 2023
Penumbra LP Coil System
K230284 · Penumbra, Inc. · Oct 2023
Target Tetra Detachable Coils
K222533 · Stryker Neurovascular · 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
Numen Coil Embolization System
K203625 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Sep 2021