FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nutrisafe 2- ENFit Adaptor
K Number: K151237
·
Decision Feb 9, 2016
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
8
Applicant Total
2
Review Days
274
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Basic Information
- Device Name
- Nutrisafe 2- ENFit Adaptor
- K Number
- K151237
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vygon
- Date Received
- May 11, 2015
- Decision Date
- February 9, 2016
- Product Code
- PIO
- 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 |
|---|---|---|---|
| PIO | Enteral Specific Transition Connectors | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PIO), ordered by most recent decision date.
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AMT Enteral Transition Adapters
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FDA Class 2
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Other Clearances by Vygon
| K Number | Device Name | ||
|---|---|---|---|
| K141026 | LEADERFLEX | Jul 30, 2014 | Substantially Equivalent |