Nutricair Enteral Syringe with ENFit— 510(k) K231300
Substantially EquivalentCair Lgl
FDA 510(k) clearance K231300 for Nutricair Enteral Syringe with ENFit, Substantially Equivalent on 2023-10-06. Applicant: Cair Lgl. Device class: 2.
Clearance details
- Applicant
- Cair Lgl
- 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
- Lissieu, FR
Recent devices under product code PNR
view allMore clearances from Cair Lgl
view all- K231299 — Nutricair enteral ENFit adapter: ENFit male stepped/Christmas tree connector
- K213258 — Nasogastric Feeding Tubes - ENFit Port - PVC
- K210598 — Pediatric Nasogastric Feeding Tubes - Single ENFit Port
- K171117 — Carefusion NeutraClear Needle-free connector (EL-NC1000)
- K171118 — Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
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.