GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER— 510(k) K042427

Substantially Equivalent

Genemed, Inc.

FDA 510(k) clearance K042427 for GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, Substantially Equivalent on 2004-12-03. Applicant: Genemed, Inc..

Clearance details

Applicant: Genemed, Inc.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2004-09-08
Decision date: 2004-12-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Woodbury, CT, 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.