FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XYLOS MACRO-POROUS SURGICAL MESH
K Number: K111584
·
Decision Aug 25, 2011
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
9
Review Days
79
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- XYLOS MACRO-POROUS SURGICAL MESH
- K Number
- K111584
- 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
- Xylos Corporation
- Date Received
- June 7, 2011
- Decision Date
- August 25, 2011
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTM), ordered by most recent decision date.
Endoform Reconstructive Template - PLGA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OviTex PRS (Long-Term Resorbable)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CanGaroo RM Antibacterial Envelope
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OviTex PRS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Peri-Guard and Supple Peri-Guard
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OviTex PRS (Long Term Resorbable)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Xylos Corporation
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K081882 | MODIFICATION TO XYLOS SURGICAL MESH | Jul 11, 2008 | 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 |