510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LQCClass II

Lithotriptor, Biliary Mechanical

21 CFR 876.4500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

LQC is the FDA product code for Lithotriptor, Biliary Mechanical, a class II device type, regulated under 21 CFR 876.4500. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LQC
Device name
Lithotriptor, Biliary Mechanical
Regulation
21 CFR 876.4500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
7

Clearances, product code LQC

By decision year
11 clearances under product code LQC with a decision year between 1986 and 2004, 1991 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LQC by decision year
YearClearances
19861
19901
19914
19942
19971
20011
20041

Applicants with the most clearances

Product code LQC
Applicants holding the most 510(k) clearances under product code LQC
ApplicantClearances
Boston Scientific Corporation3
Wilson-Cook Medical Inc.2
Baxter Healthcare Corporation1
George Percy Mcgown1
Medi-Globe GmbH1
Northgate Technologies Inc.1
Olympus Corp.1
United States Endoscopy Group, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order