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BD Vacutainer Eclipse UltraFill Blood Collection Needle

FDA 510(k)

Class II (US FDA 510(k))

510(k) K181730

by Becton, Dickinson and Company

Identifiers

510(k) Number
K181730 FDA 510(k)
FDA Product Code
FMI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The BD Vacutainer Eclipse UltraFill Blood Collection Needle is a safety-engineered, multi-sample blood collection needle designed for venipuncture procedures. It incorporates a retractable safety feature to reduce the risk of needlestick injuries during and after use, while maintaining compatibility with standard blood collection tubes.

This device is intended for single-use in clinical settings, including hospitals and outpatient environments. It is supplied sterile, non-reusable, and does not contain MRI-compatible materials. The needle is available in various gauges and lengths as specified in the product documentation, with proper storage required to maintain sterility before use. Its regulatory status includes FDA 510(k) clearance under the General Hospital advisory committee.

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: BD Vacutainer® Eclipse™ blood collection needle | BD, BD Vacutainer® Eclipse™ blood collection needle | BD, BD Vacutainer Eclipse UltraFill Blood Collection Needle

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K181730 24 fields · synced Sep 18, 2026