# K171956: Sterile Endoscope Biopsy Sampling Needle

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Detain Medical Devices Co., Ltd.
- Decided: Dec 12, 2017 after 166 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K894632 (1989). 68 ancestors in all.
No later device cites it as a predicate yet.
1 of 69 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160229: Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle, Cook Ireland, Ltd. (2016) Summary page 4.

## Indications for use
The Sterile endoscope biopsy sampling needle is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope.

Source page: https://510kreport.com/device/K171956
Methodology: https://510kreport.com/methodology