Clearance Summary
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 received FDA 510(k) clearance under submission number K131721, sponsored by Comed Medical Systems Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2014-07-22.
- Submission: K131721
- Applicant / Sponsor: Comed Medical Systems Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5990
- Decision date: 2014-07-22
Classification & Regulation
This clearance is catalogued under FDA product code LNS and 21 CFR 876.5990, within the Gastroenterology, Urology review panel as a Class II device.