LNSClass II

Lithotriptor, Extracorporeal Shock-Wave, Urological

21 CFR 876.5990 / Gastroenterology, Urology

LNS is the FDA product code for Lithotriptor, Extracorporeal Shock-Wave, Urological, a class II device type, regulated under 21 CFR 876.5990. As of 2026-09-10, FDA records hold 56 510(k) clearances under this code, the most recent dated 2026-04-29, and one recall.

Classification record

Product code: LNS
Device name: Lithotriptor, Extracorporeal Shock-Wave, Urological
Regulation: 21 CFR 876.5990
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: No
Ingested clearances: 56
Ingested recalls: 1

Clearances, product code LNS

By decision year

56 clearances under product code LNS with a decision year between 2001 and 2026, 2001 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code LNS by decision year
Year	Clearances
2001	9
2002	4
2003	2
2004	8
2005	1
2006	4
2007	4
2008	2
2009	1
2011	3
2012	3
2013	2
2014	2
2015	2
2017	2
2020	1
2021	1
2023	2
2025	1
2026	2

Applicants with the most clearances

Product code LNS

Applicants holding the most 510(k) clearances under product code LNS
Applicant	Clearances
Dornier Medtech America, Inc.	8
Direx Systems Corp.	7
Karl Storz Endoscopy-America, Inc.	7
Lite-Med, Inc.	3
Dornier	2
Medispec, Ltd.	2
Pck Electronic Industry & Trade Co., Ltd.	2
Siemens Medical Solutions USA, Inc.	2
Sonomotion, Inc.	2
United Medical Systems, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order