FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEPATOSTAT SET, MODEL 760X
K Number: K061796
·
Decision Nov 2, 2006
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
48
Review Days
129
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Basic Information
- Device Name
- HEPATOSTAT SET, MODEL 760X
- K Number
- K061796
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vygon Corp.
- Date Received
- June 26, 2006
- Decision Date
- November 2, 2006
- Product Code
- GAM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
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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 |
| 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 |