# K990220: Modification of Gip/Medi-Globe Ultrasound Needle System

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corp.
- Decided: Mar 31, 1999 after 68 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: 1 generation back to K935844 (1995). 1 ancestor in all.
59 later devices descend from it; 2 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)
- K935844: Gip/Medi-Globe Needle System for Ultrasonic Fna, Medi-Globe Corp. (1995) Summary page 1.

## Most influential descendants
- K051247: Sonotip II Ultrasound Needle System (2005), 58 descendants of its own
- 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

## Indications for use
The Medi-Globe Needle System for Ultrasonic FNA is designed to be used with the Pentax FG32, 34, 36, 38 UA ultrasound endoscopes 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/K990220
Methodology: https://510kreport.com/methodology