510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LQRClass II

Dislodger, Stone, Biliary

21 CFR 876.5010 / Gastroenterology, Urology
FDA source (opens on fda.gov)

LQR is the FDA product code for Dislodger, Stone, Biliary, a class II device type, regulated under 21 CFR 876.5010. As of , FDA records hold 38 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
LQR
Device name
Dislodger, Stone, Biliary
Regulation
21 CFR 876.5010
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
38
Ingested recalls
11

Clearances, product code LQR

By decision year
38 clearances under product code LQR with a decision year between 1985 and 2026, 1992 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LQR by decision year
YearClearances
19851
19861
19893
19903
19924
19932
19941
19953
20001
20071
20092
20131
20174
20183
20191
20201
20211
20231
20242
20251
20261

Applicants with the most clearances

Product code LQR
Applicants holding the most 510(k) clearances under product code LQR
ApplicantClearances
Boston Scientific Corporation6
Cook Incorporated4
Olympus Medical Systems Corp.3
Wilson-Cook Medical Inc.3
Cook Inc.2
Ideal Medical, Inc.2
Wiltek Medical, Inc.2
Annex Medical, Inc.1
Cape Tech Medical Products1
Hangzhou AGS MedTech Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 31 companies shown, in name order