EXF — Bag, Bile Collecting Class II

FDA Device Classification

Classification Details

Product Code
EXF
Device Class
Class II
Regulation Number
876.5010
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K003078merit medical systemsMERIT DRAINAGE DEPOTDecember 11, 2000
K990428remington medicalDRAINAGE BAGAugust 12, 1999
K980005medical device technologiesMANAN D BAGJanuary 30, 1998
K961986manan medical productsMANAN D BAGMarch 13, 1997
K963849manan medical productsMANAN D BAGDecember 13, 1996
K943663navarre biomedicalNAVARRE 600 ML DRAINAGE BAGSeptember 8, 1994
K911129medical technologies of georgiaMMG BILE BAGAugust 7, 1991
K903449uresilURESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SETSeptember 12, 1990
K901844uresilURESIL TRU-CLOSE DRAINAGE BAGJune 1, 1990