K242888 is an FDA 510(k) clearance for the Electrohydraulic Lithotriptor (TCS-B3-II). This device is classified as a Lithotriptor, Electro-hydraulic (Class II - Special Controls, product code FFK).
Submitted by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on March 21, 2025, 179 days after receiving the submission on September 23, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4480.
| 510(k) Number | K242888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2024 |
| Decision Date | March 21, 2025 |
| Days to Decision | 179 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFK — Lithotriptor, Electro-hydraulic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4480 |