FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
U&U Enteral Syringe
K Number: K160855
·
Decision Nov 22, 2016
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
32
Applicant Total
10
Review Days
239
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Basic Information
- Device Name
- U&U Enteral Syringe
- K Number
- K160855
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U&U Medical Technology Co, Ltd.
- Date Received
- March 28, 2016
- Decision Date
- November 22, 2016
- Product Code
- PNR
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PNR | Enteral Syringes With Enteral Specific Connectors | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PNR), ordered by most recent decision date.
Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
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| K143629 | U&U Bowie-Dick Test Pack | May 19, 2015 | Substantially Equivalent |
| K132553 | U&U STERILE PISTON SYRINGE WITHOUT NEEDLE | Feb 27, 2014 | Substantially Equivalent |
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| K132552 | U&U STERILE HYPODERMIC NEEDLE | Nov 13, 2013 | Substantially Equivalent |