FDA 510(k)

3D-SHAPER

K-Number: K220822 · 2022-12-09

Decision Date2022-12-09

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 2022-12-09 under approval number K220822. 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 2022-12-09. It is manufactured by 3D-Shaper Medical S.L. The 510(k) number is K220822.

When was 3D-SHAPER approved by the FDA?

3D-SHAPER received FDA 510(k) clearance on 2022-12-09, under approval number K220822.

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

K2510223D-SHAPER

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.