510(k) K231325

Corplex P / Theracor P / Allacor P by Stimlabs, LLC — Product Code KGN

K231325 is an FDA 510(k) premarket notification submitted by Stimlabs, LLC for the device "Corplex P / Theracor P / Allacor P". The FDA issued a decision of Substantially Equivalent on February 2, 2024. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Stimlabs, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2024
Date Received
May 8, 2023
Clearance Type
Traditional
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