meso-relle (AAL34, AAL36, AM30G)— 510(k) K161255

Substantially Equivalent

Biotekne Srl

FDA 510(k) clearance K161255 for meso-relle (AAL34, AAL36, AM30G), Substantially Equivalent on 2017-01-19. Applicant: Biotekne Srl.

Clearance details

Applicant: Biotekne Srl
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2016-05-03
Decision date: 2017-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Casalecchio Di Reno, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.