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Prostate Biopsy Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K770122

by Cook, Inc.

Identifiers

510(k) Number
K770122 FDA 510(k)
FDA Product Code
KNW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1075 FDA 510(k)
Regulation Number
876.1075 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Prostate Biopsy Needle is a biopsy needle classified under the nomenclature code 530_10_40_20 (Histological Needles, Biopsy, Core). It is designed to obtain tissue core specimens for histological examination during transrectal or transperineal prostate biopsy procedures. The needle features an 18-gauge design with an 19 mm sample notch to ensure adequate tissue retrieval, and an echogenic tip for precise imaging-guided placement.

This device is supplied as a single-use needle, packaged in boxes of 10, and is intended for use in conjunction with the Cook Bx Biopsy Device (sold separately). It is latex-free and must be handled under sterile conditions. The needle is regulated under FDA 510(k) clearance (K770122) and is classified under the KNW product code for urological biopsy instruments. Compatibility with MRI is not specified.

Frequently asked questions

What is the Prostate Biopsy Needle designed to collect during a prostate biopsy procedure?

The Prostate Biopsy Needle is specifically designed to obtain tissue core specimens for histological examination. Its 19 mm sample notch ensures that sufficient tissue is retrieved for accurate pathological analysis, making it suitable for diagnosing prostate conditions during either transrectal or transperineal biopsy procedures.

How is the Prostate Biopsy Needle packaged and intended for use, and is it reusable?

The needle is supplied as a single-use device, packaged in boxes of 10. It is not intended for reuse and must be handled under sterile conditions to maintain safety and efficacy. It is also latex-free, which reduces the risk of allergic reactions.

What gauge and imaging features does the Prostate Biopsy Needle have, and how does that benefit the procedure?

The needle is an 18-gauge design, which balances tissue retrieval with procedural ease. It also features an echogenic tip, allowing for precise imaging-guided placement during the biopsy, which helps improve accuracy and reduce complications.

Is the Prostate Biopsy Needle compatible with MRI, and what storage or handling precautions should be taken?

The device’s MRI compatibility is not specified, meaning its use in MRI environments should be confirmed with the manufacturer before application. Since it is single-use and sterile, it must be stored in its original packaging until use and handled with sterile techniques to prevent contamination.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cook® Bx™ Biopsy Needle, Cook® Bx™ Biopsy Needle, Cook Biopsy Needle by Cook Medical | Medline Industries, Inc., Cook Bx 18 Gauge 25… - Cook Medical G57955 - USA MedPremium

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cook, Inc.

Sources (1)

  • FDA 510(k) K770122 24 fields · synced Sep 19, 2026