FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
K Number: K093123
·
Decision May 13, 2010
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
6
Review Days
223
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Basic Information
- Device Name
- BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
- K Number
- K093123
- 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
- Biomerix Corporation
- Date Received
- October 2, 2009
- Decision Date
- May 13, 2010
- Product Code
- FTL
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Biomerix Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K112499 | BIOMERIX COMPOSITE SURGICAL MESH | Dec 23, 2011 | Substantially Equivalent |
| K112567 | BIOMERIX ASSURE | Dec 23, 2011 | Substantially Equivalent |
| K082941 | BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 | Jan 7, 2009 | Substantially Equivalent |
| K070961 | BIOMERIX SURGICAL MESH, MODEL: RCR-01 | Feb 25, 2008 | Substantially Equivalent |
| K043371 | BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER | Feb 3, 2005 | Substantially Equivalent |