AXCAN UTERINE SUCCION INJECTOR— 510(k) K842943

Substantially Equivalent

Axcan Scientific Corp.

FDA 510(k) clearance K842943 for AXCAN UTERINE SUCCION INJECTOR, Substantially Equivalent on 1984-09-21. Applicant: Axcan Scientific Corp..

Clearance details

Applicant: Axcan Scientific Corp.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1984-07-25
Decision date: 1984-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.