# K231422: Precision GI

- Pathway: 510(k) (Traditional)
- Applicant: Limaca Medical, Ltd.
- Decided: Aug 28, 2023 after 103 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: 3 generations back to K910964 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212423: EndoDrill® Model X, Bibbinstruments AB (2023) Summary page 4.

## Indications for use
Precision GI is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Source page: https://510kreport.com/device/K231422
Methodology: https://510kreport.com/methodology