# K210946: Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Aug 12, 2021 after 135 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 K904987 (1991). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192101: Medone Ultra, Medextra, Medax Srl Unipersonale (2020) Summary page 5.
- K181803: Medax Biopsy Systems III, Medax Srl Unipersonale (2018) Summary page 5.
- K160423: Perineologic Access Needle, Corbin Clinical Resources, LLC (2016) Summary page 5.

## Most influential descendants
- K261196: Promisemed VeriEcto Automatic Biopsy Needles (2026), 0 descendants of its own

## 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. Co-Axial Biopsy Device is mainly used to guide the insertion of biopsy needle into the soft tissue under imaging control (ultrasound, X-ray, CT, etc.). It is not intended for use in bone. Semi-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. When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures.

Source page: https://510kreport.com/device/K210946
Methodology: https://510kreport.com/methodology