# K213683: Promisemed Fine Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Apr 22, 2022 after 151 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: 1 generation back to K970872 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970872: Pan (Chiba Aspirating Needle), Gallini Intl., Inc. (1997) Summary page 5.

## Most influential descendants
- K244018: Disposable Biopsy Needle (2025), 0 descendants of its own

## Indications for use
It is to be used for taking cytological and histological biopsies of soft tissue.

Source page: https://510kreport.com/device/K213683
Methodology: https://510kreport.com/methodology