# K981166: Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214

- Pathway: 510(k) (Traditional)
- Applicant: Inrad
- Decided: Jun 22, 1998 after 83 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 K895897 (1989). 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)
- K974446: Manan Automatic Cutting Needle, Manan Medical Products, Inc. (1998) Summary page 1.
- K895897: Manan Prostatic Biopsy Needle, Manan Medical Products, Inc. (1989) Summary page 1.

## Most influential descendants
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own
- K013109: Sonopsy (2002), 0 descendants of its own

## Indications for use
The Accucore Biopsy Needle can be used for obtaining core and/or aspiration biopsies of various tissues (prostate, lung, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For breast biopsy this product is for diagnosis only - not for therapeutic use.

Source page: https://510kreport.com/device/K981166
Methodology: https://510kreport.com/methodology