ENFit Oral / Enteral Syringe
FDA 510(k) clearance K190502 · decided 2019-08-06
Clearance details
- K-number
- K190502
- Device name
- ENFit Oral / Enteral Syringe
- Applicant
- Jiangsu Caina Medical Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2019-03-01
- Decision date
- 2019-08-06
- Days to decision
- 158 days
- Clearance type
- Traditional
- Product code
- PNR
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jiangyin, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit recall (Z-0847-2024) | Cardinal Health 200, LLC | 2024-02-02 |
| Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection Syst recall (Z-0848-2024) | Cardinal Health 200, LLC | 2024-02-02 |
| Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection Sy recall (Z-0849-2024) | Cardinal Health 200, LLC | 2024-02-02 |
| Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection Sy recall (Z-0850-2024) | Cardinal Health 200, LLC | 2024-02-02 |