# K111529: Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core Tissue Biopsy Needle Model MCN-

- Pathway: 510(k) (Traditional)
- Applicant: Insert Molding Solutions, Inc.
- Decided: Jul 29, 2011 after 57 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 K883469 (1989). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092059: RP Cutting Needle, Riverpoint Medical (2009) Summary page 1.
- K883469: Bard (R) Aspiration Biopsy System, C.R. Bard, Inc. (1989) Summary page 1.
- K994272: Automated Core Biopsy Device, Promex, Inc. (2000) Summary page 1.

## Most influential descendants
- K162588: Möller Medical Biopsy Needles and Systems (2017), 1 descendant of its own
- K242128: Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (2025), 0 descendants of its own

## Indications for use
The M-CORE disposable biopsy needle is intended for use with the Bard® Magnum® biopsy instrument in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. The M-CORE needle is not intended for use in bone.

Source page: https://510kreport.com/device/K111529
Methodology: https://510kreport.com/methodology