Meso Wound Matrix
FDA 510(k) K112888 · Kensey Nash Corporation
510(k) numberK112888
Submission
- Device name
- Meso Wound Matrix
- Applicant
- Kensey Nash Corporation
Exton, PA, US - Received
- September 30, 2011
- Decision date
- February 10, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Implant
- Yes
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| K260669 | Endoform Dermal TemplateKGN · Traditional | Aroa Biosurgery , Ltd. | 06/24/2026SE |
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| K073519 | Quickcat Extraction Catheter, Model 60090-01QEZ · Special | 03/28/2008SE |
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Questions and answers
When was Meso Wound Matrix cleared by the FDA?
Meso Wound Matrix (K112888) received a 510(k) decision of Substantially Equivalent on February 10, 2012, 133 days after the submission was received.
What is the product code of K112888?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.