BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA— 510(k) K921722

Substantially Equivalent

Bard Reproductive Systems

FDA 510(k) clearance K921722 for BARD(R) LEVENTHAL(TM) GYNE-FLO(TM) CANNULA, Substantially Equivalent on 1994-05-02. Applicant: Bard Reproductive Systems.

Clearance details

Applicant: Bard Reproductive Systems
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1992-04-09
Decision date: 1994-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tewksbury, MA, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.