INTEGRA Wound Matrix (Macro-Channels)
FDA 510(k) K210128 · Integra LifeSciences Corporation
510(k) numberK210128
Submission
- Device name
- INTEGRA Wound Matrix (Macro-Channels)
- Applicant
- Integra LifeSciences Corporation
Princeton, NJ, US - Received
- January 19, 2021
- Decision date
- October 8, 2021
- 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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Questions and answers
When was INTEGRA Wound Matrix (Macro-Channels) cleared by the FDA?
INTEGRA Wound Matrix (Macro-Channels) (K210128) received a 510(k) decision of Substantially Equivalent on October 8, 2021, 262 days after the submission was received.
What is the product code of K210128?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.