# K962568: Acri Iliac Crest Aspiration Biopsy Needles

- Pathway: 510(k) (Traditional)
- Applicant: Gallini Intl., Inc.
- Decided: Nov 25, 1996 after 147 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Promedical - Jamshidi style biopsy needle: named in the summary without a submission number

## Indications for use
The device is intended to be used for drawing osteomedullary substances from the iliac crest.

Source page: https://510kreport.com/device/K962568
Methodology: https://510kreport.com/methodology