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Chiba Style Biopsy Needle

by Kormed, Inc. 510(k)

Active United States

510(k) K944044

Overview

The Chiba Style Biopsy Needle is a medical device designed for aspiration biopsy procedures. It is used to perform aspirations and injections for the collection of tissue samples from controlled areas.

This device is supplied as a single-use instrument and is subject to FDA 510(k) authorization. Users should consult specific product documentation for information regarding MRI safety, as compatibility varies by reference number. The needle is available in multiple gauges and lengths to accommodate various clinical requirements.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SEKD Traditional NumberK944044 Date3 Oct 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LRO
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SEKD

Other devices from Kormed, Inc.

Questions

  • What is the primary clinical use of the Chiba Style Biopsy Needle?

    This device is specifically designed for aspiration biopsy procedures. It facilitates the collection of tissue samples through controlled aspirations and injections.

  • Is the Chiba Style Biopsy Needle intended for reuse?

    No, this device is supplied as a single-use instrument. It should be disposed of after a single procedure to maintain patient safety and prevent cross-contamination.

  • Are there different sizes available for this needle?

    Yes, the needle is manufactured in multiple gauges and lengths. This variety allows clinicians to select the appropriate dimensions to accommodate specific clinical requirements.

  • Is this needle compatible with MRI equipment?

    MRI compatibility varies depending on the specific reference number of the needle. Users must consult the individual product documentation provided with the device to confirm safety for MRI environments.