# K141334: Reusable Guide

- Pathway: 510(k) (Traditional)
- Applicant: Koelis
- Decided: Jul 11, 2014 after 51 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: 1 generation back to K875128 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K875128: Trans/R Needle Guide, CIVCO Medical Instruments Co., Inc. (1988) Summary page 1.

## Most influential descendants
- K180970: Disposable guides KDNG00 (2018), 0 descendants of its own

## Indications for use
The reusable guide is dedicated for transrectal diagnosis ultrasound needle /instrument guided procedure.

Source page: https://510kreport.com/device/K141334
Methodology: https://510kreport.com/methodology