Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental— 510(k) K151632

Substantially Equivalent

Medela AG

FDA 510(k) clearance K151632 for Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental, Substantially Equivalent on 2015-11-05. Applicant: Medela AG.

Clearance details

Applicant: Medela AG
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2015-06-17
Decision date: 2015-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar, CH

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Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

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.