# K962905: TX Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Gallini S.R.L.
- Decided: Oct 11, 1996 after 78 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 K951598 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951598: Pro-B Biopsy Needle, Promedical, Ltd. (1995) Summary page 1.

## Indications for use
This device is an automated, disposable and adjustable biopsy instrument designed for ultimate accuracy in obtaining high quality histological core samples, with three different choice of penetration depth and obtaining histological samples from 0.8 to 1.9 mm length.

Source page: https://510kreport.com/device/K962905
Methodology: https://510kreport.com/methodology