# K172309: Endoscopic Ultrasound Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Tech (Nanjing) Co., Ltd.
- Decided: Sep 29, 2017 after 60 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904667 (1990). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070129: Sonotip II Ultrasound Needle System, Medi-Globe Corporation (2007) Summary page 5.
- K083802: Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025, Medi-Globe Corporation (2009) Summary page 5.
- K160845: Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device, Boston Scientific Corporation (2016) Summary page 5.

## Most influential descendants
- K212852: Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic Ultrasound Aspiration Needle (2021), 0 descendants of its own

## Recalls of this device
- Mar 12, 2018 · Class II · Z-1877-2018: The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the hu
- Mar 12, 2018 · Class II · Z-1878-2018: The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the hu

## Indications for use
The Endoscopic Ultrasound Aspiration Needle is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.

Source page: https://510kreport.com/device/K172309
Methodology: https://510kreport.com/methodology