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Becton Dickinson Dispos. Syringes Plunger Tip Mod.

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K930321

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930321 Date17 May 1993ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Becton Dickinson Disposable Syringes Plunger Tip Modified is a single-use hypodermic syringe designed for fluid administration or withdrawal. This device falls under the category of disposable syringes, intended for general hospital use. The modified plunger tip enhances usability while maintaining compatibility with standard syringe systems. It is classified under product code FMF and is intended for one-time clinical applications.

These syringes are supplied as sterile, single-use devices, ensuring patient safety and infection control. They are regulated under FDA 510(k) clearance (K930321) and fall under the General Hospital advisory committee classification. The device is intended for use in clinical settings where precision fluid handling is required. Storage instructions are not specified, but standard sterile storage practices apply. The device is not reusable and must be discarded after a single use.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Becton Dickinson Disposable Syringes Plunger Tip Modified designed for?

    The Becton Dickinson Disposable Syringes Plunger Tip Modified is specifically designed for fluid administration or withdrawal in clinical settings. Its modified plunger tip improves usability while remaining compatible with standard syringe systems, making it ideal for applications requiring precision, such as injections or blood draws in hospitals.

  • Are these syringes reusable or single-use?

    These syringes are intended for single-use only. They are classified as disposable medical devices, ensuring patient safety and infection control by preventing reuse. After a single clinical application, they must be discarded to comply with sterile procedure standards.

  • How are these syringes supplied, and what sterility status do they have?

    The syringes are supplied as sterile, single-use devices, packaged for immediate clinical use. Sterility is maintained to meet infection control requirements in healthcare environments, ensuring reliability for procedures like injections or fluid extraction.

  • What storage instructions apply to these syringes?

    While specific storage instructions are not detailed in the device data, standard sterile storage practices should be followed. This includes keeping them in a clean, dry environment, protected from contamination, and away from direct sunlight or extreme temperatures to preserve sterility and functionality.

  • What distinguishes this syringe from standard disposable syringes?

    The key distinction is the modified plunger tip, which enhances usability without compromising compatibility with existing syringe systems. This design improvement is intended to make fluid handling more efficient for clinicians during procedures, particularly in general hospital settings.