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FDA 510(k)

3D-SHAPER

K-Number: K251022 · 2025-09-05

Applicant3D-Shaper Medical S.L
Decision Date2025-09-05
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D-SHAPER is a medical device manufactured by 3D-Shaper Medical S.L. It received FDA 510(k) clearance on 2025-09-05 under approval number K251022. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D-SHAPER?

3D-SHAPER is a medical device that received FDA 510(k) clearance on 2025-09-05. It is manufactured by 3D-Shaper Medical S.L. The 510(k) number is K251022.

When was 3D-SHAPER approved by the FDA?

3D-SHAPER received FDA 510(k) clearance on 2025-09-05, under approval number K251022.

What company makes 3D-SHAPER?

3D-SHAPER is manufactured by 3D-Shaper Medical S.L.

What is the FDA product code for 3D-SHAPER?

The FDA product code for 3D-SHAPER is KGI.

Other Devices by 3D-Shaper Medical S.L

K2208223D-SHAPER

Related Devices (Code: KGI)

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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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