# K201166: Temno Elite Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Aug 28, 2020 after 119 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: 4 generations back to K950732 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171953: Bard Mission Disposable Core Biopsy Instrument, Bard Peripheral Vascular, Inc. (2017) Summary page 4.

## Indications for use
The Temno Elite Biopsy System is intended for use in obtaining biopsies from soft tissues such as liver, kidney, breast, prostate, spleen, lung, lymph nodes, thyroid, and various soft tissue masses. It is NOT intended for use in bone. The Valved Coaxial Introducer Needle and Standard Coaxial Introducer Needles are intended for use as guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, prostate, spleen, lung, lymph nodes, thyroid, and various soft tissue masses. It is NOT intended for use in bone.

Source page: https://510kreport.com/device/K201166
Methodology: https://510kreport.com/methodology