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LJH — System, Irrigation, Urological Class II

FDA Device Classification

FDA product code LJH covers "System, Irrigation, Urological", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LJH
Device Class
Class II
Regulation Number
876.5130
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K162992karl storz endoscopy americaKarl Storz UROMAT E.A.S.I.July 7, 2017
K070873amsino intlAMSURE BLADDER IRRIGATION SETDecember 19, 2007
K071832medical scientificMODIFCATION TO: SPYGLASS IRRIGATION SYSTEMSeptember 18, 2007
K063700medical scientificSPYGLASS IRRIGATION SYSTEMFebruary 8, 2007
K062551nexus medicalNEXUS IRRIGATION TUBING SETDecember 15, 2006
K042457w.o.m. world of medicineURO PROOctober 25, 2004
K040094kosin technologiesPIGGYBACK IRRIGATING SYSTEMApril 15, 2004
K023808international medsurg connectionIRRIGATION SETSMarch 10, 2003
K010607benlanMED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001November 28, 2001
K010122g.u.-tekCONTINUOUS FLOW Y-TUBINGJune 4, 2001
K001325northgate technologiesFLO ASSISTANT, MODEL 4-250-00August 18, 2000
K990909mtp medical technical promotionMTP UROPUMP DISPOSABLE TUBING SETJune 9, 1999
K981615karl storz endoscopy-americaKSEA UROPUMPJuly 8, 1998
K980808future medical systemsENDO FMS UROLOGYMay 8, 1998
K971982karl storz endoscopy-americaKARL STORZ MODEL 203020 20 EQUIMATAugust 12, 1997
K970946medline industriesMEDLINE Y-TYPE TUR/BLADDER IRRIGATION SETJune 10, 1997
K962670national healthcare mfgNHMC IRRIGATION TRAYAugust 14, 1996
K960787baxter healthcareTUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSMay 14, 1996
K943361northgate technologiesNORTHGATE FLOW ASSIST TUBING FOR UROLOGYSeptember 29, 1995
K952583aquintelAQUISENAugust 24, 1995

FDA data resources