MEDELA SINGLE USE SILC CUP, MODEL 077.0791— 510(k) K041579

Substantially Equivalent

Medela AG

FDA 510(k) clearance K041579 for MEDELA SINGLE USE SILC CUP, MODEL 077.0791, Substantially Equivalent on 2005-04-21. Applicant: Medela AG.

Clearance details

Applicant: Medela AG
Product code: Code HDB
Advisory panel: Obstetrics/Gynecology
Date received: 2004-06-14
Decision date: 2005-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar Zug, CH

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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.