Clearance Summary
Electrohydraulic Lithotriptor (TCS-B3-II) received FDA 510(k) clearance under submission number K242888, sponsored by Guangzhou Potent Medical Equipment Joint-Stock 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 2025-03-21.
- Submission: K242888
- Applicant / Sponsor: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4480
- Decision date: 2025-03-21
Classification & Regulation
This clearance is catalogued under FDA product code FFK and 21 CFR 876.4480, within the Gastroenterology, Urology review panel as a Class II device.