Becton Dickinson Dispos. Syringes Plunger Tip Mod.
by Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) K930321
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK930321 | Date17 May 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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
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.