Biopsy needles

Forsvall biopsy gun

by Xaga Surgical AB

A hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. 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 reusable device.

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Forsvall biopsy gun models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
Mech-00669Length 25 cm Not statedAvailable

FDA clearances

  • 510(k) K242128 February 2025

Procedures that use biopsy needles

Frequently asked questions

What is Forsvall biopsy gun used for?

A hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. 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 reusable device.

Who makes Forsvall biopsy gun?

Forsvall biopsy gun is made by Xaga Surgical AB. It is listed under biopsy needles and systems in our device library.

What sizes does Forsvall biopsy gun come in?

Sizes listed for Forsvall biopsy gun: Length: 25 cm. Confirm availability with the manufacturer's instructions for use.

Is Forsvall biopsy gun MRI safe?

The FDA device database entry for Forsvall biopsy gun does not state its MRI safety status. Check the labeling before MRI.

Is Forsvall biopsy gun FDA cleared?

Forsvall biopsy gun is covered by FDA submission K242128.

How do I contact a Xaga Surgical AB sales representative?

Xaga Surgical AB has not listed representatives on LA Vascular yet. Visit the Xaga Surgical AB company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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