Kensey Nash Ecm Surgical Patch
FDA 510(k) K094061 · Kensey Nash Corporation
510(k) numberK094061
Submission
- Device name
- Kensey Nash Ecm Surgical Patch
- Applicant
- Kensey Nash Corporation
Exton, PA, US - Received
- December 31, 2009
- Decision date
- May 18, 2010
- 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 Kensey Nash Ecm Surgical Patch cleared by the FDA?
Kensey Nash Ecm Surgical Patch (K094061) received a 510(k) decision of Substantially Equivalent on May 18, 2010, 138 days after the submission was received.
What is the product code of K094061?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.