Omnipod Insulin Management System, Omnipod DASH Insulin Management System— 510(k) K182630
Substantially EquivalentInsulet Corporation
FDA 510(k) clearance K182630 for Omnipod Insulin Management System, Omnipod DASH Insulin Management System, Substantially Equivalent on 2019-01-08. Applicant: Insulet Corporation.
Clearance details
- Applicant
- Insulet Corporation
- Product code
- Code LZG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Billerica, MA, US
Adverse events under product code LZG
product code LZG- Death
- 104
- Injury
- 12,022
- Malfunction
- 135,004
- Other
- 1
- Total
- 147,131
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.