# K180970: Disposable guides KDNG00

- Pathway: 510(k) (Traditional)
- Applicant: Koelis
- Decided: Jul 10, 2018 after 88 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K875128 (1988). 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)
- K141334: Reusable Guide, Koelis (2014) Summary page 4.

## Indications for use
The disposable guide KDNGOO is dedicated for endocavity diagnosis ultrasound needle guided procedure. It is intended for clinicians and assistant clinicians, in clinic and hospital, to guide linear instrument with a transrectal approach.

Source page: https://510kreport.com/device/K180970
Methodology: https://510kreport.com/methodology