EXF · Class II · 21 CFR 876.5010

FDA Product Code EXF: Bag, Bile Collecting

Leading manufacturers include Uresil Corp., Manan Medical Products, Inc. and Merit Medical Systems, Inc..

9
Total
9
Cleared
103d
Avg days
1990
Since

FDA 510(k) Cleared Bag, Bile Collecting Devices (Product Code EXF)

9 devices
1–9 of 9
Cleared Dec 11, 2000
MERIT DRAINAGE DEPOT
K003078
Merit Medical Systems, Inc.
Gastroenterology & Urology · 69d
Cleared Jan 30, 1998
MANAN D BAG
K980005
Medical Device Technologies, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 13, 1997
MANAN D BAG
K961986
Manan Medical Products, Inc.
Gastroenterology & Urology · 296d
Cleared Dec 13, 1996
MANAN D BAG
K963849
Manan Medical Products, Inc.
Gastroenterology & Urology · 79d
Cleared Sep 12, 1990
URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET
K903449
Uresil Corp.
Gastroenterology & Urology · 44d
Cleared Jun 01, 1990
URESIL TRU-CLOSE DRAINAGE BAG
K901844
Uresil Corp.
Gastroenterology & Urology · 38d

About Product Code EXF - Regulatory Context