TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER— 510(k) K030346

Substantially Equivalent

Fmd, LLC

FDA 510(k) clearance K030346 for TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, Substantially Equivalent on 2003-05-02. Applicant: Fmd, LLC.

Clearance details

Applicant: Fmd, LLC
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2003-02-03
Decision date: 2003-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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.