Clearance Summary
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER received FDA 510(k) clearance under submission number K030346, sponsored by Fmd, LLC. 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 2003-05-02.
- Submission: K030346
- Applicant / Sponsor: Fmd, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5990
- Decision date: 2003-05-02
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.