# K261196: Promisemed VeriEcto Automatic Biopsy Needles

- Pathway: 510(k) (Special)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: May 12, 2026 after 29 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: 5 generations back to K904987 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210946: Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles, Promisemed Hangzhou Meditech Co., Ltd. (2021) Summary page 5.

## Indications for use
Automatic Biopsy Needles are intended in obtaining biopsy samples from soft tissues such as liver, kidney, prostate, breast, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Source page: https://510kreport.com/device/K261196
Methodology: https://510kreport.com/methodology