# K242888: Electrohydraulic Lithotriptor (TCS-B3-II)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Decided: Mar 21, 2025 after 179 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923822 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230488: EL27-Compact; Sterile EHL-Probes, Walz Elektronik GmbH (2023) Summary page 6.

## Indications for use
The Electrohydraulic Lithotriptor is intended to be used with Potent Medical disposable electrohydraulic lithotripsy (EHL) probes for disintegration of concernments in the bile duct.

Source page: https://510kreport.com/device/K242888
Methodology: https://510kreport.com/methodology