AB VACUUM EXTRACTOR SILC-CUP— 510(k) K841492

Substantially Equivalent

Medela, Inc.

FDA 510(k) clearance K841492 for AB VACUUM EXTRACTOR SILC-CUP, Substantially Equivalent on 1984-05-07. Applicant: Medela, Inc..

Clearance details

Applicant: Medela, Inc.
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 1984-04-10
Decision date: 1984-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.