YI XIN STERILE SYRINGE FOR SINGLE USE
FDA 510(k) clearance K050999 · decided 2005-09-02
Clearance details
- K-number
- K050999
- Device name
- YI XIN STERILE SYRINGE FOR SINGLE USE
- Applicant
- Jiangxi Sanxin (Eversincere) Medical Devices Group
- Decision
- Substantially Equivalent
- Date received
- 2005-04-20
- Decision date
- 2005-09-02
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Nanchang, Jiangxi, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a cas recall (Z-0005-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |
| 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case recall (Z-0006-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |
| 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per recall (Z-0007-2024) | Fresenius Medical Care Holdings, Inc. | 2023-10-06 |