# K202813: URO-TOUCH 9 French Probe

- Pathway: 510(k) (Traditional)
- Applicant: Northgate Technologies, Inc.
- Decided: Jun 14, 2021 after 263 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 5.

## Indications for use
The Northgate Technologies Inc. AUTOLITH®URO-TOUCH 9 Fr Probe, bipolar disposable EHL is designed to be used with the Northgate Technologies Inc. AUTOLITH®URO-TOUCH unit/generator for the fragmentation of renal calculi located in the kidneys and urinary bladder.

Source page: https://510kreport.com/device/K202813
Methodology: https://510kreport.com/methodology