Optima Coil System (OptiOne Coil System)
K-Number: K254221 · 2026-01-27
ApplicantBalt USA, LLC
Decision Date2026-01-27
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Optima Coil System (OptiOne Coil System) is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2026-01-27 under approval number K254221. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Optima Coil System (OptiOne Coil System)?
Optima Coil System (OptiOne Coil System) is a medical device that received FDA 510(k) clearance on 2026-01-27. It is manufactured by Balt USA, LLC. The 510(k) number is K254221.
When was Optima Coil System (OptiOne Coil System) approved by the FDA?
Optima Coil System (OptiOne Coil System) received FDA 510(k) clearance on 2026-01-27, under approval number K254221.
What company makes Optima Coil System (OptiOne Coil System)?
Optima Coil System (OptiOne Coil System) is manufactured by Balt USA, LLC.
What is the FDA product code for Optima Coil System (OptiOne Coil System)?
The FDA product code for Optima Coil System (OptiOne Coil System) is HCG.
Other Devices by Balt USA, LLC
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K161429Target Detachable CoilsStryker Neurovascular
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K160832Penumbra Smart CoilPenumbra, Inc.
K160096InZone Detachment SystemStryker Neurovascular
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.