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510(k) K220759

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

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

Other clearances by Armis Biopharma, Inc.

  • K202777 — VeriFixx™ Small Bone Implant (November 17, 2020)

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  • K231023 — ERBEJET® 2 System (June 15, 2023)
  • K220964 — VERSAJET Hydrosurgery System (III) (May 16, 2023)
  • K221504 — BD Surgiphor™ Antimicrobial Irrigation System (October 14, 2022)
  • K222804 — Irrisept Antimicrobial Wound Lavage (September 22, 2022)
  • K210987 — IRRIGO Wound Wash Jet System (May 31, 2022)
  • K213616 — BD Surgiphor Antimicrobial Irrigation System (March 23, 2022)
  • K210536 — Irrisept Antimicrobial Wound Lavage (May 28, 2021)
  • K202222 — Irrisept Wound Debridement and Cleansing System (December 14, 2020)