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Bard Monopty Disposable Core Biopsy Instrument

FDA 510(k)

Class II (US FDA 510(k))

510(k) K910190

by C. R. Bard, Inc.

Identifiers

510(k) Number
K910190 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
SEKD FDA 510(k)

The Bard Monopty Disposable Core Biopsy Instrument is a sterile, single-use core biopsy device designed to collect tissue samples from soft tissues or organs during biopsy procedures. It is available in multiple sizes including 14G, 16G, 18G, and 20G, with specific models such as the 121616 featuring a 16-gauge needle and 16 cm length, and the 121610 featuring a 16-gauge needle and 10 cm needle length. The instrument is designed for ergonomic, one-handed use to provide control and ease of handling during procedures.

The device is supplied as a sterile, single-use kit and is intended for use in clinical settings where tissue sampling is required. It has received FDA 510(k) clearance under product code KNW and was cleared on August 16, 1991, under K910190. The instrument is not reusable and must be disposed of after a single use. No MRI safety information is provided in the data.

Frequently asked questions

What is the Bard Monopty Disposable Core Biopsy Instrument used for?

The Bard Monopty Disposable Core Biopsy Instrument is designed to collect tissue samples from soft tissues or organs during biopsy procedures, providing control and ease of handling through its ergonomic, one-handed use design for clinical tissue sampling.

How is the Bard Monopty Disposable Core Biopsy Instrument supplied and is it reusable?

The device is supplied as a sterile, single-use kit and is intended for one-time use only; it must be disposed of after each procedure and is not designed for reuse, reprocessing, or resterilization.

What sizes and models are available for the Bard Monopty Disposable Core Biopsy Instrument?

The instrument is available in multiple gauges including 14G, 16G, 18G, and 20G, with specific models such as the 121616 (16-gauge, 16 cm length) and the 121610 (16-gauge, 10 cm needle length) to accommodate different procedural needs.

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: Mission™ Disposable Core Biopsy Instrument - BD, Bard Monopty Disposable Core Biopsy Instrument 121616, Bard Monopty Disposable Core Biopsy Instrument 121610, CR Bard MONOPTY Disposable Core Biopsy Instrument - BIOPSY, INSTRUMENT ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K910190 24 fields · synced Oct 1, 2026