U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
FDA 510(k) clearance K132553 · decided 2014-02-27
Clearance details
- K-number
- K132553
- Device name
- U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
- Applicant
- U&U Medical Technology Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-14
- Decision date
- 2014-02-27
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Changzhou, Jiangsu, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CarePoint 60 mL Syringe Without Needle, REF: 04-7560 recall (Z-0478-2023) | Allison Medical, Inc. | 2022-12-13 |