DeviceClearance

Product code LNS— Gastroenterology, Urology

Delta III Lithotripter

Classification name
Lithotriptor, Extracorporeal Shock-Wave, Urological
Device class
Class 2
Regulation
21 CFR 876.5990
Advisory panel
Gastroenterology, Urology
Total cleared
56
First cleared
Most recent

Market context for product code LNS

FDA has cleared 56 devices under product code LNS between 2001 and 2026, filed by 32 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 LNS

Adverse events under product code LNS

product code LNS
Death
4
Injury
320
Total
324

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LNS

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