# K914514: 1.9 French Lithotripter Electrode, Modification

- Pathway: 510(k) (Traditional)
- Applicant: Northgate Technologies, Inc.
- Decided: Jan 6, 1992 after 89 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K230488: EL27-Compact; Sterile EHL-Probes (2023), 2 descendants of its own
- 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

## Recalls of this device
- May 24, 2017 · Class II · Z-0073-2018: The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be

Source page: https://510kreport.com/device/K914514
Methodology: https://510kreport.com/methodology