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Interson Disposable Biopsy Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K911464

by Interson Corp

Identifiers

510(k) Number
K911464 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Interson Disposable Biopsy Needle is classified as a disposable biopsy needle under the Radiology advisory committee category. It is designed for percutaneous tissue sampling, enabling clinicians to obtain core tissue specimens for diagnostic evaluation. This single-use device is intended for use with ultrasound guidance, facilitating precise needle placement during biopsy procedures. Its construction ensures sterility and reduces the risk of cross-contamination between patients.

This device is supplied as a single-use, sterile instrument and is regulated under FDA 510(k) clearance (K911464), granted in 1991. It falls under the IYO product code and is intended for use in radiology settings. No additional regulatory status beyond the stated clearance is implied. The device is not reusable and must be discarded after a single procedure to maintain sterility and safety standards.

Frequently asked questions

What is the Interson Disposable Biopsy Needle used for?

The Interson Disposable Biopsy Needle is designed for percutaneous tissue sampling under ultrasound guidance. Clinicians use it to obtain core tissue specimens for diagnostic evaluation, ensuring accurate sampling of targeted areas during biopsy procedures.

Is the Interson Disposable Biopsy Needle reusable or single-use?

This device is explicitly intended for single-use only. Its disposable design maintains sterility and eliminates the risk of cross-contamination between patients, adhering to safety standards for biopsy procedures.

How is the Interson Disposable Biopsy Needle supplied?

The needle is supplied as a sterile, single-use instrument. Each unit is packaged individually to preserve sterility and prevent contamination, ensuring readiness for immediate use in radiology settings.

What regulatory clearance does the Interson Disposable Biopsy Needle hold?

The device holds FDA 510(k) clearance (K911464) under the Radiology advisory committee category. It was granted in 1991 and is classified as substantially equivalent to a predicate device, meeting regulatory requirements for ultrasound-guided biopsy needles.

Why should clinicians prefer a disposable biopsy needle over reusable options?

Disposable biopsy needles like the Interson model reduce the risk of infection and cross-contamination by eliminating reuse. Their sterile packaging ensures each procedure starts with a clean instrument, improving patient safety and procedural reliability.

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: INTERSON DISPOSABLE BIOPSY NEEDLE (K911464) — FDA 510 (k) | Innolitics, Interson Disposable Biopsy Needle - allmed.wiki, Interson Disposable Biopsy Needle - Beudamed, USB Ultrasound Probes for Physicians & Veterinarians: Interson Corporation

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Interson Corp
FDA Applicant
Interson Corp.

Sources (1)

  • FDA 510(k) K911464 24 fields · synced Oct 5, 2026