# K133763: Sonotip Pro and Pro Flex Ebus-Tbna Needle System

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corporation
- Decided: May 15, 2014 after 155 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: 10 generations back to K894632 (1989). 60 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 63 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091257: Medi-Globe Sonotip II Ebus-Tbna Needle System, Medi-Globe Corporation (2009) Summary page 1.

## Most influential descendants
- K231267: ClearTip (2023), 1 descendant of its own
- K250994: ClearTip FNA and FNB Types (2025), 0 descendants of its own

## Indications for use
The Sono Tip Pro and Pro Flex - TBNA Needle System is intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).

Source page: https://510kreport.com/device/K133763
Methodology: https://510kreport.com/methodology