DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)— 510(k) K011873

Name: FDA 510(k) clearance K011873
Creator: U.S. Food and Drug Administration
Published: 2001-08-31

Substantially Equivalent

Dornier

FDA 510(k) clearance K011873 for DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP), Substantially Equivalent on 2001-08-31. Applicant: Dornier. Device class: 2.

Clearance details

Applicant: Dornier
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-15
Decision date: 2001-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNS

view all

K261086 — Break Wave2026-04-29
K252913 — Break Wave2026-01-12
K242922 — Extracorporeal Shock Wave Lithotripter (U200)2025-06-18
K221903 — Delta III Pro2023-02-22
K213772 — LM-9300 Plus Lithotripter2023-01-19

More clearances from Dornier

view all

K011773 — DORNIER LITHOTRIPTER 140(DOLI 140)2001-06-22
K984349 — DORNIER MEDILAS R1999-02-04

Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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