510(k) K240277

MiroDry Wound Matrix by Reprise Biomedical, Inc. — Product Code KGN

K240277 is an FDA 510(k) premarket notification submitted by Reprise Biomedical, Inc. for the device "MiroDry Wound Matrix". The FDA issued a decision of Substantially Equivalent on March 1, 2024. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Reprise Biomedical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2024
Date Received
January 31, 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