# K214063: Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Shengwei Medical Devices Co., Ltd.
- Decided: Jun 3, 2022 after 158 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 K922939 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853312: Argon Cut Biopsy Needles, Various Sizes, Argon Medical Corp. (1985) Summary page 4.
- 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.
- K160316: SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles, M.D.L. S.R.L. (2016) Summary page 4.

## Indications for use
The Shengwei Biopsy needle consist of Model 121 Biopsy Needle, Model 111/112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle. These devices are indicated for use as follows: Model 121 Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. Model 111/112 Biopsy Needle is intended for obtaining core biopsy from samples soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone. Model 111/112 Biopsy Needle is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the abnormality. Model 131 Disposable Coaxial Biopsy Needle is intended for use with biopsy needle during soft tissue core biopsy procedures. The device is not intended for use in bone. The extent of histological abnormality cannot be reliably determined from it 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 the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Source page: https://510kreport.com/device/K214063
Methodology: https://510kreport.com/methodology