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FQH — Lavage, Jet Class II

FDA Device Classification

Classification Details

Product Code
FQH
Device Class
Class II
Regulation Number
880.5475
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253996becton, dickinson and company (bd)BD Surgiphor™ Antimicrobial Irrigation System (910110)February 25, 2026
K253445bdBD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)February 20, 2026
K231023erbe elektromedizinERBEJET® 2 SystemJune 15, 2023
K220759armis biopharmaArmis VeriCyn Wound WashMay 25, 2023
K220964smith and nephew medical limitedVERSAJET Hydrosurgery System (III)May 16, 2023
K221504bdBD Surgiphor™ Antimicrobial Irrigation SystemOctober 14, 2022
K222804irrimax corporationIrrisept Antimicrobial Wound LavageSeptember 22, 2022
K210987inoproIRRIGO Wound Wash Jet SystemMay 31, 2022
K213616becton, dickinson andBD Surgiphor Antimicrobial Irrigation SystemMarch 23, 2022
K210536irrimax corporationIrrisept Antimicrobial Wound LavageMay 28, 2021
K202222irrimax corporationIrrisept Wound Debridement and Cleansing SystemDecember 14, 2020
K202071orthophorSURGIPHOR Wound Irrigation SystemOctober 23, 2020
K192349next scienceBactisure Wound LavageJanuary 23, 2020
K161165next scienceNext Science Irrigation SolutionSeptember 7, 2016
K143115smith and nephewThe VersaJet II Hydrosurgery SystemJuly 15, 2015
K113312patrin pharmaHY-CHLO(TM)WOUND SCRUBAugust 21, 2012
K111313alcavis hdcEXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVEDecember 14, 2011
K110958smith and nephewVERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VEAugust 1, 2011
K090848premier brands of americaPREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWMJune 17, 2009
K082858alcavis internationalEXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSERMay 27, 2009