Home / Device Classification / KNQ

KNQ — Dilator, Esophageal Class II

FDA Device Classification

Classification Details

Product Code
KNQ
Device Class
Class II
Regulation Number
876.5365
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K122924boston scientificCRE FIXED WIRE BALLON DILATION CATHETEROctober 24, 2012
K093236ethicon endo-surgeryETHICON ENDO-SURGERYOPTICAL DILATORNovember 10, 2009
K090183cook endoscopyHERCULES 3 STAGE WIRE GUIDED DILATION BALLOONSeptember 25, 2009
K082995safestitch medicalSMART DILATORFebruary 6, 2009
K061937cook endoscopyCOOK ENDOSCOPY ESOPHAGEAL DILATION BALLOONDecember 1, 2006
K061787boston scientificMAXFORCE TTS SINGLE-USE BALLOON DILATORSeptember 21, 2006
K060302cordis europa, n.vINSCOPE PRECISION BALLOON DILATOR - WIRE GUIDEDApril 11, 2006
K043605cordis europa, n.vINSCOPE 3-STAGE BALLOON DILATORFebruary 4, 2005
K033936c.r. bardBARD ELIMINATOR PET BALLOON DILATORSJanuary 14, 2004
K031147ethicon endo-surgeryOPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATORJanuary 12, 2004
K023907cordisCORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BADecember 18, 2002
K002363medovationsMEDOVATIONS ESOPHAGEAL DILATORNovember 1, 2000
K993720cordisCORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETERJanuary 18, 2000
K983373b. braun/mcgawIMPACT BALLOON DILATION CATHETERJune 22, 1999
K990935pilling weck surgicalJACKSON ESOPHAGEAL DILATORMay 17, 1999
K974788boston scientificCRE(TM) BALLOON DILATATION CATHETERMarch 20, 1998
K971320boston scientificCRE BALLOON DILATATION CATHETEROctober 9, 1997
K971615tri-med specialtiesPATTISON ESOPHAGEAL DILATORJuly 24, 1997
K961438boston scientificBALLON DILATATION CATHETERJuly 31, 1996
K952656boston scientificXXL BALLOON DILATATION CATHETERJuly 19, 1995