TAMPON, UNTREATED— 510(k) K912941

Substantially Equivalent

Hygieia Healthcare , Ltd.

FDA 510(k) clearance K912941 for TAMPON, UNTREATED, Substantially Equivalent on 1992-03-06. Applicant: Hygieia Healthcare , Ltd..

Clearance details

Applicant: Hygieia Healthcare , Ltd.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1991-07-01
Decision date: 1992-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tyne And Wear, England, GB

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Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

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.