Home / 510(k) Clearances / K210987

510(k) K210987

IRRIGO Wound Wash Jet System by Inopro, Inc. — Product Code FQH

K210987 is an FDA 510(k) premarket notification submitted by Inopro, Inc. for the device "IRRIGO Wound Wash Jet System". The FDA issued a decision of Substantially Equivalent on May 31, 2022. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2022
Date Received
April 1, 2021
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 for product code FQH

  • K253996 — BD Surgiphor™ Antimicrobial Irrigation System (910110) (February 25, 2026)
  • K253445 — BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (February 20, 2026)
  • K231023 — ERBEJET® 2 System (June 15, 2023)
  • K220759 — Armis VeriCyn Wound Wash (May 25, 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)
  • 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)

FDA data resources