# K964777: TZ

- Pathway: 510(k) (Traditional)
- Applicant: Gallini Intl., Inc.
- Decided: Jan 3, 1997 after 37 days
- Product code: KNW (Instrument, Biopsy)
- 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 intended to be used to take high quality histological core samples from soft tissue, including (but not limited to) liver, kidney, prostate.

Source page: https://510kreport.com/device/K964777
Methodology: https://510kreport.com/methodology