EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1— 510(k) K131721
Substantially EquivalentComed Medical Systems Co., Ltd.
FDA 510(k) clearance K131721 for EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1, Substantially Equivalent on 2014-07-22. Applicant: Comed Medical Systems Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Comed Medical Systems Co., Ltd.
- Product code
- Code LNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.5990
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code LNS
view allAdverse 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.