NasalCEASE and BleedCEASE— 510(k) K183622

Substantially Equivalent

Les Laboratoires Brothier S.A.

FDA 510(k) clearance K183622 for NasalCEASE and BleedCEASE, Substantially Equivalent on 2019-12-02. Applicant: Les Laboratoires Brothier S.A..

Clearance details

Applicant: Les Laboratoires Brothier S.A.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2018-12-26
Decision date: 2019-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanterre, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

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.