# K051247: Sonotip II Ultrasound Needle System

- Pathway: 510(k) (Special)
- Applicant: Medi-Globe Corp.
- Decided: Jun 16, 2005 after 31 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: 2 generations back to K935844 (1995). 2 ancestors in all.
58 later devices descend from it; 3 cite it directly.
1 of 61 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990220: Modification of Gip/Medi-Globe Ultrasound Needle System, Medi-Globe Corp. (1999) Summary page 1.

## Most influential descendants
- K070129: Sonotip II Ultrasound Needle System (2007), 57 descendants of its own
- K083330: Echotip Ultra Ultrasound Needle (2009), 49 descendants of its own
- K092359: Echo Tip Ultra High Definition Ultrasound Access Needle, Model: Echo-HD-19A (2009), 16 descendants of its own
- K123676: Cellvizio 100 Series and Cellvizio Systems with Confocal Miniprobes (2013), 11 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own

## Indications for use
The SonoTip 11 Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip 11 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/K051247
Methodology: https://510kreport.com/methodology