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

System, Irrigation, Urological

21 CFR 876.5130 / Gastroenterology, Urology
FDA source (opens on fda.gov)

LJH is the FDA product code for System, Irrigation, Urological, a class II device type, regulated under 21 CFR 876.5130. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LJH
Device name
System, Irrigation, Urological
Regulation
21 CFR 876.5130
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
29
Ingested recalls
7

Clearances, product code LJH

By decision year
29 clearances under product code LJH with a decision year between 1982 and 2026, 1995 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LJH by decision year
YearClearances
19821
19831
19881
19942
19955
19962
19972
19982
19991
20001
20012
20031
20042
20061
20073
20171
20261

Applicants with the most clearances

Product code LJH
Applicants holding the most 510(k) clearances under product code LJH
ApplicantClearances
Karl Storz Endoscopy-America, Inc.5
Medical Scientific, Inc.2
Northgate Technologies Inc.2
American Cystocope Makers, Inc.1
Amsino Intl., Inc.1
Aquintel, Inc.1
B.Braun Medical, Inc.1
Baxter Healthcare Corporation1
Canadian Hospital Specialties Ltd.1
Deschutes Medical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 55 companies shown, in name order