# K962077: Bard Biopty-Cut Biopsy Needle/with Spacer

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 30, 1996 after 63 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: 1 generation back to K871390 (1987). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871390: Bard Biopty Biopsy System, C.R. Bard, Inc. (1987) Summary page 3.
- K910720: Bard Biopty-Cut Biopsy Needle with Spacer, C.R. Bard, Inc. (1991) Summary page 3.

## Most influential descendants
- K191315: Remington Medical, Inc. Automatic Cutting Needle (NAC) (2019), 0 descendants of its own
- K110112: Cell-Tissue Converter (CTC) Syringe with Needle (2011), 0 descendants of its own

## Indications for use
The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Source page: https://510kreport.com/device/K962077
Methodology: https://510kreport.com/methodology