FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO XYLOS SURGICAL MESH
K Number: K081882
·
Decision Jul 11, 2008
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
9
Review Days
9
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Basic Information
- Device Name
- MODIFICATION TO XYLOS SURGICAL MESH
- K Number
- K081882
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xylos Corporation
- Date Received
- July 2, 2008
- Decision Date
- July 11, 2008
- Product Code
- FTM
- 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Xylos Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K111584 | XYLOS MACRO-POROUS SURGICAL MESH | Aug 25, 2011 | Substantially Equivalent |
| K100984 | XYLOS VESSEL GUARD | Jul 7, 2010 | Unknown |
| K090880 | XYLOS POROUS SURGICAL MESH | May 27, 2009 | Substantially Equivalent |
| K090778 | MTA PROTECTIVE SHEET | Apr 28, 2009 | Substantially Equivalent |
| K083823 | SECURIAN TISSUE REINFORCEMENT MATRIX | Mar 18, 2009 | Substantially Equivalent |
| K023237 | XYLOS SURGICAL MESH | Mar 18, 2003 | Substantially Equivalent |
| K024054 | XYLOS XCELL ANTIMICROBIAL DRESSING | Mar 7, 2003 | Substantially Equivalent |
| K974251 | X-CELL WOUND DRESSING | Jun 22, 1998 | Substantially Equivalent |