Anti-Stick Syringe With Integral Hypodermic Needle/Vanishpoint Syringe
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K973301 FDA 510(k)
- FDA Product Code
- MEG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vanishpoint Syringe is a Class II medical device classified as an Antistick Syringe, designed for the administration of medications or withdrawal of blood. It features an integral hypodermic needle with a built-in, user-activated retraction mechanism to safely withdraw the needle into the syringe barrel after use, reducing the risk of accidental needlesticks.
This single-use, non-sterile device is intended for clinical use in general hospital settings. It is supplied in various sizes and requires activation by the user to retract the needle post-procedure. Authorized under FDA 510K and MDR, the device adheres to regulatory standards for safety and performance in healthcare environments.
Frequently asked questions
What is the primary purpose of the Vanishpoint Syringe, and where is it typically used?
The Vanishpoint Syringe is designed as an anti-stick syringe with an integrated hypodermic needle, intended for the safe administration of medications or the withdrawal of blood. It is specifically classified for use in general hospital settings, helping reduce the risk of accidental needlesticks by retracting the needle into the syringe barrel after use.
Is the Vanishpoint Syringe sterile, and how is it supplied for clinical use?
The Vanishpoint Syringe is non-sterile and intended for single-use only. It is supplied in multiple sizes (as indicated by the listed FEI numbers) and is meant to be activated by the user to retract the needle post-procedure, ensuring safe disposal.
How does the needle retraction mechanism work, and is it automatic or user-activated?
The Vanishpoint Syringe features a user-activated retraction mechanism—meaning the clinician must manually trigger the needle to retract into the syringe barrel after use. This design ensures controlled retraction while maintaining safety.
What regulatory pathways does the Vanishpoint Syringe follow, and what does that mean for its use?
The device is authorized under FDA 510K and MDR (Medical Device Regulation), indicating it has undergone regulatory review to demonstrate substantial equivalence to predicate devices. This means it meets established safety and performance standards for use in healthcare environments, particularly in general hospitals.
Are there different sizes or models available, and how would I identify the correct one for my needs?
Yes, the Vanishpoint Syringe is available in multiple sizes, as evidenced by the extensive list of FEI (Final Establishment Identification) numbers provided. These correspond to different syringe gauges or volumes, so selecting the appropriate model depends on the clinical application—such as medication dosage or blood collection volume. Always verify the specific FEI number or size against your facility’s requirements.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Anti-stick Syringe With Integral Hypodermic Needle/Vanishpoint Syringe ..., Anti-stick Syringe With Integral Hypodermic Needle Vanishpoint Syringe ..., VanishPoint Safety Syringes | Automated Retraction Technology
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K973301 | Class II | Active |
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Manufacturer
- Manufacturer
- Retractable Technologies, Inc.
Sources (2)
- FDA 510(k) K973301 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026