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Disposable Coaxial Biopsy Needle

by Suzhou Leapmed Healthcare Corporation

510(k) K212822

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212822↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK212822 Date6 Jul 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
FCG
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Disposable Coaxial Biopsy Needle is a single-use, coaxial needle designed for obtaining tissue samples from internal organs. It is classified as a Class II medical device and is used in procedures requiring precise tissue acquisition, such as biopsies of the liver, lymph nodes, breast, and other soft tissues under ultrasound guidance.

This device is intended for single-use and is supplied sterile for immediate clinical application. It is regulated under FDA 510(k) clearance and the EU Medical Device Regulation (MDR), with multiple registration numbers listed in the database. The needle is compatible with ultrasound-guided interventions and is available in various sizes as indicated by the associated product codes. Storage should follow manufacturer guidelines to maintain sterility.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of tissues or organs can the Disposable Coaxial Biopsy Needle be used to obtain samples from under ultrasound guidance?

    The Disposable Coaxial Biopsy Needle is designed for obtaining tissue samples from soft tissues, including the liver, lymph nodes, and breast. It is specifically intended for ultrasound-guided procedures, ensuring precise tissue acquisition during biopsies.

  • Is the Disposable Coaxial Biopsy Needle reusable or intended for single-use only?

    The device is explicitly labeled for single-use only, meaning it must not be reused after a single procedure. This design ensures sterility and safety for each patient, as it is supplied sterile for immediate clinical application.

  • How should the Disposable Coaxial Biopsy Needle be stored to maintain its sterility?

    Storage instructions are provided by the manufacturer to preserve sterility. Since it is supplied sterile for immediate use, it should be stored in its original packaging, protected from contamination, and kept in a clean, dry environment until ready for clinical application.

  • What regulatory pathways does the Disposable Coaxial Biopsy Needle follow in the U.S. and EU?

    In the U.S., the device has undergone FDA 510(k) clearance, demonstrating it is substantially equivalent to a predicate device. In the EU, it complies with the Medical Device Regulation (MDR), reflecting its classification as a Class II medical device. Both pathways ensure its safety and performance meet regulatory standards.

  • Are there multiple sizes or models available for the Disposable Coaxial Biopsy Needle, and how can I identify them?

    Yes, the device is available in various sizes, each corresponding to specific product codes (e.g., FCG). These codes help clinicians and buyers select the appropriate gauge or length for their procedure, ensuring compatibility with ultrasound-guided interventions and the target tissue.