SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP— 510(k) K013767
Substantially EquivalentSterling Medivations, Inc.
FDA 510(k) clearance K013767 for SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP, Substantially Equivalent on 2001-12-12. Applicant: Sterling Medivations, Inc..
Clearance details
- Applicant
- Sterling Medivations, Inc.
- Product code
- Code FRN
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Altos Hills, CA, US
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . 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.