ENFit Oral / Enteral Syringe— 510(k) K190502
Substantially EquivalentJiangsu Caina Medical Co.,Ltd
FDA 510(k) clearance K190502 for ENFit Oral / Enteral Syringe, Substantially Equivalent on 2019-08-06. Applicant: Jiangsu Caina Medical Co.,Ltd. Device class: 2.
Clearance details
- Applicant
- Jiangsu Caina Medical Co.,Ltd
- 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
- Jiangyin, CN
Recent devices under product code PNR
view allMore clearances from Jiangsu Caina Medical Co.,Ltd
view allAdverse 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 →
Recalls naming K190502
K-number listed on FDA's recall record- Z-0847-2024 — Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
- Z-0848-2024 — Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
- Z-0849-2024 — Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
- Z-0850-2024 — Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190502.
Data sourced from openFDA. This site is unofficial and independent of the FDA.