FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
K Number: K100163
·
Decision Oct 13, 2011
Classifications
1
FEI Numbers
46
Registration Numbers
47
Same Product Code
58
Applicant Total
48
Review Days
631
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Basic Information
- Device Name
- NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
- K Number
- K100163
- 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 Corp.
- Date Received
- January 20, 2010
- Decision Date
- October 13, 2011
- Product Code
- FPD
- 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 |
|---|---|---|---|
| FPD | Tube, Feeding | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Vygon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K121105 | NUTRISAFE 2 FEEDING TUBE | Dec 18, 2012 | Substantially Equivalent |
| K073493 | HEPATOSTAT SET | May 6, 2008 | Substantially Equivalent |
| K070705 | MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039 | Nov 30, 2007 | Substantially Equivalent |
| K061796 | HEPATOSTAT SET, MODEL 760X | Nov 2, 2006 | Substantially Equivalent |
| K061250 | MULTICATH EXPERT | Sep 29, 2006 | Substantially Equivalent |
| K060944 | NUTRISAFE 2 | Sep 15, 2006 | Substantially Equivalent |
| K062425 | LIFECATH S PICC AND MIDLINE CATHETER | Sep 15, 2006 | Substantially Equivalent |
| K052564 | VYGON LEADER-FLEX | Apr 5, 2006 | Substantially Equivalent |
| K052881 | VYGON LATEX FREE BIONECTOR | Mar 2, 2006 | Substantially Equivalent |
| K051248 | VYGON MICRO-ACCESS SAFETY INTRODUCER KIT | Oct 27, 2005 | Substantially Equivalent |