HYS-SURGIFLATOR VP— 510(k) K933847

Substantially Equivalent

W.O.M. World of Medicine GmbH

FDA 510(k) clearance K933847 for HYS-SURGIFLATOR VP, Substantially Equivalent on 1995-08-15. Applicant: W.O.M. World of Medicine GmbH.

Clearance details

Applicant: W.O.M. World of Medicine GmbH
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1993-08-06
Decision date: 1995-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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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.