DeviceClearance

Stardust Med— 510(k) K200736

Substantially Equivalent

I.T.S. Group S.R.L.

FDA 510(k) clearance K200736 for Stardust Med, Substantially Equivalent on 2020-06-26. Applicant: I.T.S. Group S.R.L.. Device class: 2.

Clearance details

Applicant
I.T.S. Group S.R.L.
Product code
Code GEX
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Calderara Di Reno, IT
Download summary PDFView on FDA.gov ↗

Recent devices under product code GEX

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Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

Source: openFDA MAUDE database, through . 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.