# K180450: Corvocet Biopsy System

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Mar 12, 2018 after 20 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922939 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K153337: Corvocet Biopsy System, Merit Medical Systems, Inc. (2016) Summary page 4.

## Most influential descendants
- K260517: Automatic Core Biopsy Instrument (2026), 0 descendants of its own

## Recalls of this device
- Aug 3, 2022 · Class II · Z-0137-2023: Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in
- Aug 3, 2022 · Class II · Z-0138-2023: Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in

## Indications for use
The disposable Corvocet Biopsy System is intended for use in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Source page: https://510kreport.com/device/K180450
Methodology: https://510kreport.com/methodology