Needle, prostate biopsy

Type of medical device or related product
General vs. specific use (health condition)
Intended population age
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
WHO list of priority medical devices
EMDN related code(s)
A010299
BIOPSY NEEDLES AND KITS - OTHER
GMDN related code(s)
63123
Prostate optical-guidance biopsy system handpiece/needle (A sterile, electronic, hollow tubular instrument with an integrated fibreoptic bundle and sample side-notch designed to: 1) enable in vivo, real-time analysis of prostate tissue normality or abnormality for biopsy targeting; and 2) obtain a prostate tissue specimen (via transrectal or percutaneous access). It is designed to be connected to the system’s console and consists of a handpiece with a stylet within a cannula, whose optical fibres function as an optical sensor and light transmitter between the console and the tissue; it includes a built-in motor and controls for incremental advancement of the stylet through the prostate. This is a single-use device.)