DeviceClearance

Product code LJH— Gastroenterology, Urology

AMSURE BLADDER IRRIGATION SET

Classification name
System, Irrigation, Urological
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Total cleared
29
First cleared
Most recent

Market context for product code LJH

FDA has cleared 29 devices under product code LJH between 1982 and 2026, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LJH

Recent clearances under product code LJH

Data sourced from openFDA. This site is unofficial and independent of the FDA.