510(k) K220759

Armis VeriCyn Wound Wash by Armis Biopharma, Inc. — Product Code FQH

K220759 is an FDA 510(k) premarket notification submitted by Armis Biopharma, Inc. for the device "Armis VeriCyn Wound Wash". The FDA issued a decision of Substantially Equivalent on May 25, 2023. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Armis Biopharma, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2023
Date Received
March 15, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type