# K981477: Medical Biopsy Automatic Cutting Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medical Biopsy, Inc.
- Decided: Jun 10, 1998 after 47 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 K914874 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914874: Manan Pro-Mag Automatic Biopsy Device, Manan Medical Products, Inc. (1992) Summary page 1.

## Indications for use
Medical Biopsy's Automatic Biopsy Needle is intended for use in obtaining samples of tissues or lesions from the Breast, Kidney, Prostate and Liver.

Source page: https://510kreport.com/device/K981477
Methodology: https://510kreport.com/methodology