# K963390: Biopsy Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 10, 1996 after 43 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.
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) Bard® TruGuide® Coaxial Needle: named in the summary without a submission number

## Indications for use
Biopsy Introducer Needles are devices that are used to guide procedural biopsy needles coaxially to the location of tissue masses or lesions located throughout the body.

Source page: https://510kreport.com/device/K963390
Methodology: https://510kreport.com/methodology