FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE
K Number: K860285
·
Decision Feb 11, 1986
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
48
Review Days
14
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Basic Information
- Device Name
- XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE
- K Number
- K860285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Vygon Corp.
- Date Received
- January 28, 1986
- Decision Date
- February 11, 1986
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 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 |
| K100163 | NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX | Oct 13, 2011 | 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 |