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510(k) Data Aggregation
K Number
K214063Device Name
Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
Manufacturer
Date Cleared
2022-06-03
(158 days)
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
Guangzhou Shengwei Medical Devices Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Shengwei Biopsy needle consist of Model 121 Biopsy Needle, Model 111/112 Biopsy Needle, and Model 13 1 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 essue margins be examined for completeness of removal using standard surgical procedures.
Device Description
The Shengwei Biopsy needle include semi-automatic and automatic spring powered guns (disposable). Cannula accessory is provided in a variety of sizes, designed to work with the manufacturer's semi-automatic and automatic guns to obtain and deliver a soft tissue core sample, facilitate skin and tissue penetration, sample retention and / or expulsion depending on the sample sites.
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