FDA 510(k)

3D-SHAPER

K-Number: K251022 · 2025-09-05

Decision Date2025-09-05

Product CodeKGI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

3D-SHAPER is the device name listed in this FDA 510(k) record. The listed applicant is 3D-Shaper Medical S.L. It received FDA 510(k) clearance on 2025-09-05 under 510(k) 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. The listed applicant is 3D-Shaper Medical S.L. The 510(k) number is K251022.

When did 3D-SHAPER receive FDA 510(k) clearance?

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

Who is the listed applicant for 3D-SHAPER?

The FDA 510(k) record lists 3D-Shaper Medical S.L as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing 3D-Shaper Medical S.L as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2208223D-SHAPER

Related Devices (Code: KGI)

K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K242295BunkerHill BMDBunkerHill Health K243218TBS iNsight (V4)Medimaps Group SA K220402VirtuOstO.N. Diagnostics K2208223D-SHAPER3D-Shaper Medical S.L K213760ABMD SoftwareHeartLung Corporation

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.