# K984382: Accu Guide

- Pathway: 510(k) (Traditional)
- Applicant: Tayman Medical, Inc.
- Decided: Mar 5, 1999 after 87 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K881605 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881605: Biopsy Guide, Teknar, Inc. (1988) Summary page 1.

## Indications for use
Tayman Medical AccuGuide is used to mount disposable 18 gauge x 20 centimeter automated biopsy needles to the CLI 4900 Ultrasound Probe manufactured by Capistrano Labs for the purpose of accurately guiding the needle to the site where the biopsy sample is to be taken.

Source page: https://510kreport.com/device/K984382
Methodology: https://510kreport.com/methodology