SONOLITH I-SYS LITHOTRIPER— 510(k) K083614

Substantially Equivalent

Technomed Medical Systems, SA

FDA 510(k) clearance K083614 for SONOLITH I-SYS LITHOTRIPER, Substantially Equivalent on 2009-07-27. Applicant: Technomed Medical Systems, SA.

Clearance details

Applicant: Technomed Medical Systems, SA
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-08
Decision date: 2009-07-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mount Dora, FL, 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.