ENConnect 40 mm Screw Cap to ENPlus Adapter— 510(k) K190327
Substantially EquivalentCedic S.R.L.
FDA 510(k) clearance K190327 for ENConnect 40 mm Screw Cap to ENPlus Adapter, Substantially Equivalent on 2019-04-09. Applicant: Cedic S.R.L.. Device class: 2.
Clearance details
- Applicant
- Cedic S.R.L.
- Product code
- Code PIF
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Peschiera Borromeo, IT
Recent devices under product code PIF
view allMore clearances from Cedic S.R.L.
view all- K181787 — Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
- K162254 — Cedic Enteral ENFit Transition Connectors
- K150010 — Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port
- K140581 — CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT
- K072652 — ENTERAL FEEDING SPIKE ADAPTER
Adverse events under product code PIF
product code PIF- Death
- 13
- Injury
- 122
- Other
- 1
- Total
- 136
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.