Geistlich Wound Matrix PLUS
FDA 510(k) K213607 · Geistlich Pharma AG
510(k) numberK213607
Submission
- Device name
- Geistlich Wound Matrix PLUS
- Applicant
- Geistlich Pharma AG
Wolhusen, Lu, CH - Received
- November 15, 2021
- Decision date
- April 28, 2022
- 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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| K253521 | ECMT-100 WMDKGN · Traditional | Ecm Therapeutics, Inc. | 06/18/2026SE |
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Questions and answers
When was Geistlich Wound Matrix PLUS cleared by the FDA?
Geistlich Wound Matrix PLUS (K213607) received a 510(k) decision of Substantially Equivalent on April 28, 2022, 164 days after the submission was received.
What is the product code of K213607?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.