Meso Bilayer Surgical Mesh
FDA 510(k) K132025 · Kensey Nash Corporation Dba Dsm Biomedical
510(k) numberK132025
Submission
- Device name
- Meso Bilayer Surgical Mesh
- Applicant
- Kensey Nash Corporation Dba Dsm Biomedical
Exton, PA, US - Received
- July 1, 2013
- Decision date
- October 30, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Meso Bilayer Surgical Mesh cleared by the FDA?
Meso Bilayer Surgical Mesh (K132025) received a 510(k) decision of Substantially Equivalent on October 30, 2013, 121 days after the submission was received.
What is the product code of K132025?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.