Cleared Special

K241866 - InnovaMatrix®FD (FDA 510(k) Clearance)

Jul 2024
Decision
29d
Days
-
Risk

K241866 is an FDA 510(k) clearance for the InnovaMatrix®FD. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Convatec Triad Life Sciences, LLC (Memphis, US). The FDA issued a Cleared decision on July 26, 2024, 29 days after receiving the submission on June 27, 2024.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K241866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2024
Decision Date July 26, 2024
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KGN - Wound Dressing With Animal-derived Material(s)
Device Class -