MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI— 510(k) K010340
Substantially EquivalentKarl Storz Lithotripsy-America, Inc.
FDA 510(k) clearance K010340 for MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI, Substantially Equivalent on 2001-02-13. Applicant: Karl Storz Lithotripsy-America, Inc..
Clearance details
- Applicant
- Karl Storz Lithotripsy-America, Inc.
- Product code
- Code LNS
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Culver City, CA, US
Adverse events under product code LNS
product code LNS- Death
- 4
- Injury
- 320
- Total
- 324
Source: openFDA MAUDE database, through . 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.