SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN— 510(k) K020990

Substantially Equivalent

Sterling Medivations, Inc.

FDA 510(k) clearance K020990 for SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN, Substantially Equivalent on 2002-04-10. Applicant: Sterling Medivations, Inc..

Clearance details

Applicant: Sterling Medivations, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2002-03-27
Decision date: 2002-04-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Los Altos Hills, CA, US

Download summary PDF View on FDA.gov ↗

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.