HYSTEROFLATOR 1500— 510(k) K911844

Substantially Equivalent

F.M. Wiest USA, Inc.

FDA 510(k) clearance K911844 for HYSTEROFLATOR 1500, Substantially Equivalent on 1991-11-21. Applicant: F.M. Wiest USA, Inc..

Clearance details

Applicant: F.M. Wiest USA, Inc.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1991-04-25
Decision date: 1991-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oradel, NJ, 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.