Electrohydraulic Lithotriptor (TCS-B3-II)
FDA 510(k) K242888 · Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
510(k) numberK242888
Submission
- Device name
- Electrohydraulic Lithotriptor (TCS-B3-II)
- Applicant
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Guangzhou, CN - Received
- September 23, 2024
- Decision date
- March 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FFK – Lithotriptor, Electro-Hydraulic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)FFK · Traditional | Guangzhou Potent Medical Equipment Joint-Stock… | 03/21/2025SE |
| K230488 | EL27-Compact; Sterile EHL-ProbesFFK · Traditional | Walz Elektronik GmbH | 08/31/2023SE |
| K202813 | URO-TOUCH 9 French ProbeFFK · Traditional | Northgate Technologies, Inc. | 06/14/2021SE |
| K191124 | Swiss LithoClast TrilogyFFK · Special | E.M.S Electro Medical Systems S.A | 05/29/2019SE |
| K162119 | UreTron PF Series ProbeFFK · Special | Med-Sonics Corp. | 08/29/2016SE |
| K160198 | UreTron MultiProbe Lithotripter SystemFFK · Special | Med-Sonics Corp. | 02/23/2016SE |
| K132795 | Cyberwand Sterile Probe SetFFK · Special | Cybersonics, Inc. | 11/26/2013SE |
| K130368 | Autolith Touch; Uro TouchFFK · Traditional | Northgate Technologies, Inc. | 11/15/2013SE |
| K123038 | Swiss LithobreakerFFK · Traditional | E.M.S Electro Medical Systems S.A | 01/16/2013SE |
| K120303 | Cyberwand Dual Action Ultrasonic Lithotripsy SystemFFK · Abbreviated | Cybersonics, Inc. | 06/05/2012SE |
More from Cybersonics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…GEX · Traditional | 03/06/2026SE |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40)GEX · Traditional | 01/24/2026SE |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)GEX · Traditional | 11/24/2025SE |
| K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…GEX · Traditional | 11/24/2025SE |
| K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…GEX · Traditional | 11/20/2025SE |
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)FFK · Traditional | 03/21/2025SE |
Questions and answers
When was Electrohydraulic Lithotriptor (TCS-B3-II) cleared by the FDA?
Electrohydraulic Lithotriptor (TCS-B3-II) (K242888) received a 510(k) decision of Substantially Equivalent on March 21, 2025, 179 days after the submission was received.
What is the product code of K242888?
The FDA product code is FFK – Lithotriptor, Electro-Hydraulic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.