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FDA 510(k)

LONGY Implant and LONGY-N Implant

K-Number: K241462 · 2025-02-11

ApplicantNoris Medical , Ltd.
Decision Date2025-02-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LONGY Implant and LONGY-N Implant is a medical device manufactured by Noris Medical , Ltd.. It received FDA 510(k) clearance on 2025-02-11 under approval number K241462. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LONGY Implant and LONGY-N Implant?

LONGY Implant and LONGY-N Implant is a medical device that received FDA 510(k) clearance on 2025-02-11. It is manufactured by Noris Medical , Ltd.. The 510(k) number is K241462.

When was LONGY Implant and LONGY-N Implant approved by the FDA?

LONGY Implant and LONGY-N Implant received FDA 510(k) clearance on 2025-02-11, under approval number K241462.

What company makes LONGY Implant and LONGY-N Implant?

LONGY Implant and LONGY-N Implant is manufactured by Noris Medical , Ltd..

What is the FDA product code for LONGY Implant and LONGY-N Implant?

The FDA product code for LONGY Implant and LONGY-N Implant is DZE.

Other Devices by Noris Medical , Ltd.

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Related Devices (Code: DZE)

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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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