Cleared Special

K241724 - Cytal® Wound Matrix (FDA 510(k) Clearance)

Also includes:
Cytal® Burn Matrix
Jul 2024
Decision
27d
Days
Risk

K241724 is an FDA 510(k) clearance for the Cytal® Wound Matrix. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on July 11, 2024, 27 days after receiving the submission on June 14, 2024.

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

Submission Details

510(k) Number K241724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2024
Decision Date July 11, 2024
Days to Decision 27 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

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