# K083802: Sonotip II 25-Gauge Ultrasound Needle System, Models Gus-01-18-025 and Gus-01-27-025

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corporation
- Decided: Mar 20, 2009 after 88 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: 4 generations back to K935844 (1995). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 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 1.
- K051247: Sonotip II Ultrasound Needle System, Medi-Globe Corp. (2005) Summary page 1.
- K013356: Wilson-Cook Ultrasound Biopsy Needle, Wilson-Cook Medical, Inc. (2001)

## Most influential descendants
- K172309: Endoscopic Ultrasound Aspiration Needle (2017), 1 descendant of its own
- K212852: Areus (TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt (TM) Endoscopic Ultrasound Aspiration Needle (2021), 0 descendants of its own

## Indications for use
The SonoTip II25-gauge Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.

Source page: https://510kreport.com/device/K083802
Methodology: https://510kreport.com/methodology