FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARIETEX PROGRIP MESH
K Number: K081050
·
Decision May 28, 2008
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
332
Applicant Total
31
Review Days
44
Basic Information
- Device Name
- PARIETEX PROGRIP MESH
- K Number
- K081050
- 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
- SOFRADIM PRODUCTION
- Date Received
- April 14, 2008
- Decision Date
- May 28, 2008
- 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 SOFRADIM PRODUCTION
| K Number | Device Name | ||
|---|---|---|---|
| K150091 | Versatex Monofilament Mesh | May 26, 2015 | Substantially Equivalent |
| K143386 | Progrip Laparoscopic Self-Fixating Mesh | Mar 13, 2015 | Substantially Equivalent |
| K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh | Nov 14, 2014 | Substantially Equivalent |
| K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh | Oct 28, 2014 | Substantially Equivalent |
| K142091 | PARIETENE MACROPOROUS MESH | Oct 17, 2014 | Substantially Equivalent |
| K140941 | PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH | May 7, 2014 | Substantially Equivalent |
| K131969 | SYMBOTEX(TM) COMPOSITE MESH | Aug 22, 2013 | Substantially Equivalent |
| K123479 | PROGRIP LAPAROSCOPIC SELF-FIXATING MESH | Dec 11, 2012 | Substantially Equivalent |
| K120897 | PROGRIP LAPARSCOPIC SELF-FIXATING MESH | Jun 29, 2012 | Substantially Equivalent |
| K120506 | PARIETEX COMPOSITE VENTRAL PATCH | Jun 13, 2012 | Substantially Equivalent |