IRRIGO Wound Wash Jet System

FDA 510(k) K210987 · Inopro, Inc.

Substantially Equivalent

510(k) numberK210987

Submission

Device name
IRRIGO Wound Wash Jet System
Applicant
Inopro, Inc.
Cowansville, CA
Received
April 1, 2021
Decision date
May 31, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FQH – Lavage, Jet
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5475
Specialty
General Hospital

Other 510(k)s with product code FQH

510(k)DeviceApplicantDecision
K253996BD Surgiphor™ Antimicrobial Irrigation System (910110)FQH · Special Becton, Dickinson and Company (BD)02/25/2026SE
K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)FQH · Traditional Bd02/20/2026SE
K231023ERBEJET® 2 SystemFQH · Traditional Erbe Elektromedizin GmbH06/15/2023SE
K220759Armis VeriCyn Wound WashFQH · Traditional Armis Biopharma, Inc.05/25/2023SE
K220964VERSAJET Hydrosurgery System (III)FQH · Traditional Smith & Nephew Medical Limited05/16/2023SE
K221504BD Surgiphor™ Antimicrobial Irrigation SystemFQH · Traditional Bd10/14/2022SE
K222804Irrisept Antimicrobial Wound LavageFQH · Special Irrimax Corporation09/22/2022SE
K213616BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional Becton, Dickinson and Company03/23/2022SE
K210536Irrisept Antimicrobial Wound LavageFQH · Traditional Irrimax Corporation05/28/2021SE
K202222Irrisept Wound Debridement and Cleansing SystemFQH · Traditional Irrimax Corporation12/14/2020SE

Questions and answers

When was IRRIGO Wound Wash Jet System cleared by the FDA?

IRRIGO Wound Wash Jet System (K210987) received a 510(k) decision of Substantially Equivalent on May 31, 2022, 425 days after the submission was received.

What is the product code of K210987?

The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.