Cleared Special

Cytal? Wound Matrix; Cytal? Burn Matrix

K241724 · Acell, Inc. · General & Plastic Surgery
Jul 2024
Decision
27d
Days
—
Risk

About This 510(k) Submission

K241724 is an FDA 510(k) clearance for the Cytal? Wound Matrix; Cytal? Burn Matrix, 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 review panel.

Submission Details

510(k) Number K241724 FDA.gov
FDA Decision Cleared 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 —