K242888
- 510(k) number
- K242888
- Device name
- Electrohydraulic Lithotriptor (TCS-B3-II)
- Applicant
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. CN
- Product code
- FFK — Lithotriptor, Electro-Hydraulic
- Decision date
- 2025-03-21
- Date received
- 2024-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242888.pdf
Official FDA record: K242888
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.