FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
K Number: K090679
·
Decision Apr 17, 2009
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
8
Review Days
32
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Basic Information
- Device Name
- VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
- K Number
- K090679
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vioptix, Inc.
- Date Received
- March 16, 2009
- Decision Date
- April 17, 2009
- Product Code
- MVR
- 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 |
|---|---|---|---|
| MVR | Device, Anastomotic, Microvascular | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Vioptix, Inc.
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|---|---|---|---|
| K233488 | Intra.Ox 2.0 Handheld Tissue Oximeter | Feb 28, 2024 | Substantially Equivalent |
| K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter | May 3, 2022 | Substantially Equivalent |
| K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter | Sep 16, 2019 | Substantially Equivalent |
| K163472 | Intra.Ox Handheld Tissue Oximeter | Nov 16, 2017 | Substantially Equivalent |
| K133983 | INTRA. OX HANDHELD TISSUE OXIMETER | Sep 12, 2014 | Substantially Equivalent |
| K141234 | ODISSEY TISSUE OXIMETER | Jul 1, 2014 | Substantially Equivalent |
| K042657 | VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 | Jan 10, 2005 | Substantially Equivalent |