SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL— 510(k) K201936
Substantially EquivalentGilero, LLC
FDA 510(k) clearance K201936 for SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL, Substantially Equivalent on 2021-05-06. Applicant: Gilero, LLC.
Clearance details
- Applicant
- Gilero, LLC
- Product code
- Code KPE
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Adverse events under product code KPE
product code KPE- Malfunction
- 1,000
- Other
- 1
- Total
- 1,001
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.