510(k) K220759
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