Cleared Traditional

Armis VeriCyn Wound Wash

K220759 · Armis Biopharma, Inc. · General & Plastic Surgery

May 2023

Decision

436d

Days

Class 2

Risk

About This 510(k) Submission

K220759 is an FDA 510(k) clearance for the Armis VeriCyn Wound Wash, a Lavage, Jet (Class II — Special Controls, product code FQH), submitted by Armis Biopharma, Inc. (Fort Collins, US). The FDA issued a Cleared decision on May 25, 2023, 436 days after receiving the submission on March 15, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5475.

Submission Details

510(k) Number	K220759 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2022
Decision Date	May 25, 2023
Days to Decision	436 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF