Side-notch biopsy gun, single-use

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Innologic Pty Ltd

Class:

Class IIa

Manufactured by:

German Medical Technology Beijing Co Ltd 15-18A Jingsheng South Street 4 Jinqiao Science & Technology Industrial Base, Zhongguancun Science Park Tongzhou District, Beijing, 101102 China

Therapeutic area:

58990 - Side-notch biopsy gun, single-use

Therapeutic indications:

A sterile hand-operated surgical instrument designed for the automatic extraction of a small tissue sample from an anatomic structure of the body (i.e., a biopsy), while causing minimal surrounding tissue damage, for pathological examination/testing. It has a spring-loaded mechanism intended for transcutaneous insertion of its distal needle-like portion. It typically has a trocar-like distal tip with a side-notch cutter; when activated, a sharp, sliding cannula slices a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device

Authorization status:

A

Authorization date:

2017-05-17