# K960509: 18 Gauge Tru-Cut Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Apr 4, 1996 after 59 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Baxter 14 Gauge Tru-Cut Biopsy Needle: named in the summary without a submission number

## Most influential descendants
- K162588: Möller Medical Biopsy Needles and Systems (2017), 1 descendant of its own
- K242128: Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (2025), 0 descendants of its own

## Indications for use
The 18 gauge Tru-Cut Biopsy Needle is a device that introduces a cannula into the soft tissue such as breast, lungs, lymph nodes and prostate, etc. for diagnostic evaluation.

Source page: https://510kreport.com/device/K960509
Methodology: https://510kreport.com/methodology