AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP— 510(k) K980976

Substantially Equivalent

Hollister, Inc.

FDA 510(k) clearance K980976 for AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP, Substantially Equivalent on 1998-08-21. Applicant: Hollister, Inc..

Clearance details

Applicant: Hollister, Inc.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1998-03-16
Decision date: 1998-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, US

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Adverse events under product code HDB

product code HDB

Death: 7
Total: 7

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.