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Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle

by Shandong Zhushi Pharmaceutical Group Co., Ltd 510(k)

Active United States

510(k) K212033

Overview

The Disposable Sterile Syringe is a medical device available with or without a needle, featuring luer or luer-lock connections, and is designed for insulin administration or hypodermic injections. This single-use device is manufactured by Shandong Zhushi Pharmaceutical Group Co., Ltd. and is intended for sterile medical procedures requiring precise fluid delivery.

The syringe is supplied in a sterile condition and is designed for single-use only. It is available in various sizes as specified by the model numbers. The device has received FDA 510(k) clearance with the product code FMF and was determined to be substantially equivalent, with authorization received on 2022-08-17.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212033 Date17 Aug 2022ClearedStatusActive

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: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
FMF
Models / Variants
FDA applicant
Shandong Zhushi Pharmaceutical Group Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Shandong Zhushi Pharmaceutical Group Co., Ltd

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Questions

  • What is the purpose of the Disposable Sterile Syringe?

    The Disposable Sterile Syringe is designed for medical procedures requiring precise fluid delivery, specifically for insulin administration or hypodermic injections. It features luer or luer-lock connections for secure attachment to needles or other medical devices.

  • Is this syringe reusable or single-use only?

    This syringe is designed for single-use only. It is supplied in a sterile condition and should not be reused to ensure patient safety and prevent contamination or infection.

  • What sizes and models are available for this syringe?

    The syringe is available in various sizes as specified by the model numbers. The specific sizes and model options should be confirmed with the manufacturer based on the intended use and requirements.

  • What is the regulatory status of this syringe?

    The Disposable Sterile Syringe has received FDA 510(k) clearance with product code FMF. It was determined to be substantially equivalent, with authorization received on 2022-08-17.