Monoject Enteral Syringe with ENFit Connector— 510(k) K161963
Substantially EquivalentCovidien
FDA 510(k) clearance K161963 for Monoject Enteral Syringe with ENFit Connector, Substantially Equivalent on 2016-09-01. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- Product code
- Code PNR
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
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Adverse events under product code PNR
product code PNR- Other
- 6
- Total
- 6
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.