# K963794: Punctureneedle

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Mar 19, 1998 after 545 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: 2 generations back to K813338 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760775: Terumo Disposable Spinal Needle, Terumo America, Inc. (1976) Summary page 1.
- K851953: Hawkin Needle, Wilson-Cook Medical, Inc. (1985) Summary page 1.
- K851957: Chiba Needle, Wilson-Cook Medical, Inc. (1985) Summary page 1.
- K961185: Daum Biopsyneedle, Ferguson Medical (1996) Summary page 1.

## Indications for use
The PunctureNeedle device is intended for use in puncturing precise anatomical locations (including but not limited to cysts, lesions, fluid spaces, etc.) and aspirating or injecting various fluids or contents. The device may be utilized under MRI guidance.

Source page: https://510kreport.com/device/K963794
Methodology: https://510kreport.com/methodology