U&U Enteral Syringe
FDA 510(k) clearance K160855 · decided 2016-11-22
Clearance details
- K-number
- K160855
- Device name
- U&U Enteral Syringe
- Applicant
- U&U Medical Technology Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-28
- Decision date
- 2016-11-22
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- PNR
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Changzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.