510(k) K241724

Cytal® Wound Matrix; Cytal® Burn Matrix by Acell, Inc. — Product Code KGN

K241724 is an FDA 510(k) premarket notification submitted by Acell, Inc. for the device "Cytal® Wound Matrix; Cytal® Burn Matrix". The FDA issued a decision of Substantially Equivalent on July 11, 2024. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Acell, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2024
Date Received
June 14, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type