# K191315: Remington Medical, Inc. Automatic Cutting Needle (NAC)

- Pathway: 510(k) (Traditional)
- Applicant: Remington Medical, Inc.
- Decided: Jul 12, 2019 after 58 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
Longest line of descent: 2 generations back to K871390 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962077: Bard Biopty-Cut Biopsy Needle/with Spacer, C.R. Bard, Inc. (1996) Summary page 4.

## Recalls of this device
- Dec 2, 2022 · Class II · Z-0771-2023: The stylet is longer than specified on the label

## Indications for use
Remington Medical, Inc. Automatic Cutting Needle (NAC) 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/K191315
Methodology: https://510kreport.com/methodology