FFK
- Product code
- FFK
- Device name
- Lithotriptor, Electro-Hydraulic
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.4480
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 61 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243032 | 2025-03-21 | Guangzhou Potent Medical Equipment Joi… | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe … | |
| K242888 | 2025-03-21 | Guangzhou Potent Medical Equipment Joi… | Electrohydraulic Lithotriptor (TCS-B3-II) |
Official FDA classification page: FFK
Classification and pathway per current FDA publications. Data from openFDA (CC0).