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

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.

Clearance details

Applicant: Dornier
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-15
Decision date: 2001-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

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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.