STERILE DISPOSABLE SYRINGE(3 PIECES)— 510(k) K852819

Substantially Equivalent

Fabersanitas, S.A.

FDA 510(k) clearance K852819 for STERILE DISPOSABLE SYRINGE(3 PIECES), Substantially Equivalent on 1985-09-20. Applicant: Fabersanitas, S.A..

Clearance details

Applicant: Fabersanitas, S.A.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1985-07-01
Decision date: 1985-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 15-50004 Zaragoza-Spain, ES

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.