# K935844: Gip/Medi-Globe Needle System for Ultrasonic Fna

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Globe Corp.
- Decided: Feb 13, 1995 after 432 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
No predicates in its family tree.
60 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K990220: Modification of Gip/Medi-Globe Ultrasound Needle System (1999), 59 descendants of its own
- 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

Source page: https://510kreport.com/device/K935844
Methodology: https://510kreport.com/methodology