# K091257: Medi-Globe Sonotip II Ebus-Tbna Needle System

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corporation
- Decided: May 8, 2009 after 9 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: 9 generations back to K894632 (1989). 59 ancestors in all.
3 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)
- 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.
- K050503: Single Use Aspiration Needle NA-201SX-4022, Olympus Medical Systems Corporation (2005) Summary page 1.

## Most influential descendants
- K133763: Sonotip Pro and Pro Flex Ebus-Tbna Needle System (2014), 2 descendants of its own
- K231267: ClearTip (2023), 1 descendant of its own
- K250994: ClearTip FNA and FNB Types (2025), 0 descendants of its own

## Indications for use
The SonoTip II Endobronchial Ultrasound-Guided Transbronchial Fine Needle Aspiration, (EBUS-TBNA) Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II EBUS-TBNA Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Tracheobronchial Tree and Gastrointestinal Tract.

Source page: https://510kreport.com/device/K091257
Methodology: https://510kreport.com/methodology