510(k) K242828

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

K242828 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 October 18, 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
October 18, 2024
Date Received
September 19, 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