# K230488: EL27-Compact; Sterile EHL-Probes

- Pathway: 510(k) (Traditional)
- Applicant: Walz Elektronik GmbH
- Decided: Aug 31, 2023 after 189 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: 2 generations back to K923822 (1993). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130368: Autolith Touch; Uro Touch, Northgate Technologies, Inc. (2013) Summary page 4.
- K914514: 1.9 French Lithotripter Electrode, Modification, Northgate Technologies, Inc. (1992) Summary page 4.
- K914515: 3 French Lithotripter Electrode, Modification, Northgate Technologies, Inc. (1992) Summary page 4.
- K914516: 9 French Lithotripter Electrode, Modification, Northgate Technologies, Inc. (1992) Summary page 4.
- K913955: 1.9 French Lithotripter Electrode, Modification, Northgate Technologies, Inc. (1991) Summary page 4.

## Most influential descendants
- K243032: EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (2025), 0 descendants of its own
- K242888: Electrohydraulic Lithotriptor (TCS-B3-II) (2025), 0 descendants of its own

## Indications for use
The EL27-Compact is a device to be used together with EHL-probes from Walz Elektronik GmbH for disintegration of concernments in the upper and lower urinary tract and in gastroenterology, particularly in the bile duct.

Source page: https://510kreport.com/device/K230488
Methodology: https://510kreport.com/methodology