FDA Product Code LQR: Dislodger, Stone, Biliary
FDA product code LQR covers biliary stone dislodgers used endoscopically or percutaneously to break up and remove calculi from the bile ducts.
These basket, balloon, or mechanical lithotripsy devices are used to capture, fragment, and extract stones from the common bile duct during ERCP procedures, avoiding the need for surgical common bile duct exploration.
LQR devices are Class II medical devices, regulated under 21 CFR 876.5010 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Boston Scientific Corp, Cook Incorporated and Wilson-Cook Medical, Inc..
38
Total
38
Cleared
123d
Avg days
1985
Since
38 devices
Cleared
Dec 23, 1992
MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS
Boston Scientific Corp
Gastroenterology & Urology
51d
Cleared
Dec 17, 1992
BILIARY STONE DISLODGER
Annex Medical, Inc.
Gastroenterology & Urology
44d
Cleared
Mar 20, 1992
OVER THE WIRE STONE BASKET
Medical Dynamics, Inc.
Gastroenterology & Urology
101d
Cleared
Dec 28, 1990
GLASSMAN STONE EXTRACTION SET
Wilson-Cook Medical, Inc.
Gastroenterology & Urology
88d
Cleared
Sep 12, 1990
WITTICH NITINOL STONE BASKET
Cook, Inc.
Gastroenterology & Urology
69d
Cleared
Sep 12, 1990
COPE NITINOL STONE BASKET
Cook, Inc.
Gastroenterology & Urology
69d
Cleared
Dec 21, 1989
WILTEK BALLOON STONE EXTRACTOR
Wiltek Medical, Inc.
Gastroenterology & Urology
143d
Cleared
Dec 21, 1989
WILTEK STONE EXTRACTOR
Wiltek Medical, Inc.
Gastroenterology & Urology
143d
Cleared
Oct 31, 1986
HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER
Oscor Medical Corp.
Gastroenterology & Urology
87d
Cleared
Apr 22, 1985
ENDOSOPIC STENE MANIPULATING BALLOON
Mill-Rose Laboratory
Gastroenterology & Urology
73d