# K962907: Skinny,Franseen,Wescott Needles

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Oct 23, 1996 after 90 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- 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) Baxter Skinny Chiba Needles: named in the summary without a submission number
- (no number) Hart Enterprises Soft Tissue Biopsy Needle: named in the summary without a submission number

## Recalls of this device
- Jun 2, 2003 · Not classified · Z-0942-03: The product was shipped prior to being sterilized.

## Indications for use
FNA needles are devices that are used to obtain samples through the aspiration of fluid (containing cells) from soft tissues such as breast, liver, kidney, pancreas and lung, etc. to analyze size, shape and structure of cells for diagnostic evaluation or monitor treatment.

Source page: https://510kreport.com/device/K962907
Methodology: https://510kreport.com/methodology