# K153337: Corvocet Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Mar 25, 2016 after 127 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 K922939 (1993). 2 ancestors in all.
2 later devices descend 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)
- K133948: Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument, Bard Peripheral Vascular, Inc. (2014) Summary page 4.

## Most influential descendants
- K180450: Corvocet Biopsy System (2018), 1 descendant of its own
- K260517: Automatic Core Biopsy Instrument (2026), 0 descendants of its own

## 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/K153337
Methodology: https://510kreport.com/methodology