SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE— 510(k) K013104

Substantially Equivalent

Sterling Medivations, Inc.

FDA 510(k) clearance K013104 for SIMPLICITY QD SOFT INFUSION SET FOR USE BY PEOPLE WITH DIABETES IN INFUSE INSULIN SUBCUTANEOUSLY FROM A PUMP OR SYRINGE, Substantially Equivalent on 2001-10-02. Applicant: Sterling Medivations, Inc..

Clearance details

Applicant: Sterling Medivations, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2001-09-17
Decision date: 2001-10-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Los Altos Hills, CA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.