SIMPLISSE ELECTRIC BREASTFEEDING COMPANION— 510(k) K093648

Substantially Equivalent

Simplisse, Inc.

FDA 510(k) clearance K093648 for SIMPLISSE ELECTRIC BREASTFEEDING COMPANION, Substantially Equivalent on 2010-07-14. Applicant: Simplisse, Inc..

Clearance details

Applicant: Simplisse, Inc.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2009-11-25
Decision date: 2010-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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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.