FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
TIGR Matrix Surgical Mesh
K Number: K163005
·
Decision Jul 27, 2017
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
10
Applicant Total
2
Review Days
272
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Basic Information
- Device Name
- TIGR Matrix Surgical Mesh
- K Number
- K163005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Novus Scientific AB
- Date Received
- October 28, 2016
- Decision Date
- July 27, 2017
- Product Code
- OWT
- 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 |
|---|---|---|---|
| OWT | Mesh, Surgical, Absorbable, Abdominal Hernia | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Novus Scientific AB
| K Number | Device Name | ||
|---|---|---|---|
| K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Mar 26, 2020 | Substantially Equivalent |