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FDA 510(k)

Optima Coil System (OptiBlock Line Extension)

K-Number: K242582 · 2024-09-27

ApplicantBalt USA, LLC
Decision Date2024-09-27
Product CodeHCG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Optima Coil System (OptiBlock Line Extension) is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2024-09-27 under approval number K242582. 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 (OptiBlock Line Extension)?

Optima Coil System (OptiBlock Line Extension) is a medical device that received FDA 510(k) clearance on 2024-09-27. It is manufactured by Balt USA, LLC. The 510(k) number is K242582.

When was Optima Coil System (OptiBlock Line Extension) approved by the FDA?

Optima Coil System (OptiBlock Line Extension) received FDA 510(k) clearance on 2024-09-27, under approval number K242582.

What company makes Optima Coil System (OptiBlock Line Extension)?

Optima Coil System (OptiBlock Line Extension) is manufactured by Balt USA, LLC.

What is the FDA product code for Optima Coil System (OptiBlock Line Extension)?

The FDA product code for Optima Coil System (OptiBlock Line Extension) is HCG.

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Other Devices by Balt USA, LLC

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Related Devices (Code: HCG)

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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.

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