# K130368: Autolith Touch; Uro Touch

- Pathway: 510(k) (Traditional)
- Applicant: Northgate Technologies, Inc.
- Decided: Nov 15, 2013 after 274 days
- Product code: FFK (Lithotriptor, Electro-Hydraulic)
- Device class: 2
- Regulation: 21 CFR 876.4480
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923822 (1993). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923822: Autolith-Iehl, Northgate Technologies, Inc. (1993) Summary page 2.

## 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
- K202813: URO-TOUCH 9 French Probe (2021), 0 descendants of its own

## Recalls of this device
- Apr 13, 2022 · Class II · Z-1235-2022: Product labeled incorrectly.
- Oct 25, 2021 · Class II · Z-0333-2022: The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
- Mar 10, 2020 · Class II · Z-1883-2020: As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
- Mar 10, 2020 · Class II · Z-1884-2020: Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

## Indications for use
The AUTOLITH® TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of biliary calculi. The AUTOLITH® URO-TOUCH unit is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of renal calculi.

Source page: https://510kreport.com/device/K130368
Methodology: https://510kreport.com/methodology