Clearance Summary
TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER received FDA 510(k) clearance under submission number K042561, sponsored by Fmd, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2004-10-12.
- Submission: K042561
- Applicant / Sponsor: Fmd, LLC
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5990
- Decision date: 2004-10-12
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.