3D-SHAPER— 510(k) K220822

Substantially Equivalent

3D-Shaper Medical S.L

FDA 510(k) clearance K220822 for 3D-SHAPER, Substantially Equivalent on 2022-12-09. Applicant: 3D-Shaper Medical S.L.

Clearance details

Applicant: 3D-Shaper Medical S.L
Product code: Code KGI
Advisory panel: Radiology
Date received: 2022-03-21
Decision date: 2022-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.