HYS-SURGIFLATOR— 510(k) K924523

Name: FDA 510(k) clearance K924523
Creator: U.S. Food and Drug Administration
Published: 1995-04-11

Substantially Equivalent

W.O.M. World of Medicine GmbH

FDA 510(k) clearance K924523 for HYS-SURGIFLATOR, Substantially Equivalent on 1995-04-11. Applicant: W.O.M. World of Medicine GmbH. Device class: 2.

Clearance details

Applicant: W.O.M. World of Medicine GmbH
Product code: Code HIG
Device class: Class 2
Regulation: 21 CFR 884.1700
Advisory panel: Obstetrics/Gynecology
Date received: 1992-09-08
Decision date: 1995-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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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.