# K161409: M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem

- Pathway: 510(k) (Traditional)
- Applicant: Mermaid Medical A/S
- Decided: Aug 2, 2016 after 74 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: 2 generations back to K950732 (1995). 2 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974814: Manan (TM) Super-Core Biopsy Needles, Medical Device Technologies, Inc. (1998) Summary page 4.

## Most influential descendants
- K171953: Bard Mission Disposable Core Biopsy Instrument (2017), 5 descendants of its own
- K222865: M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle (2023), 1 descendant of its own
- K250032: Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (2025), 0 descendants of its own
- K241793: Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle (2025), 0 descendants of its own
- K233031: M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle (2024), 0 descendants of its own

## Indications for use
(N301) Disposable Semi-Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination. (N302) Coaxial Introducer Needle is used as a guiding needle for (N301)

Source page: https://510kreport.com/device/K161409
Methodology: https://510kreport.com/methodology