Identifiers
- 510(k) Number
- K161170 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 Eclipse Hypodermic Needle is a single-lumen, safety-engineered hypodermic needle designed for intravenous, intramuscular, and subcutaneous injections. Its primary function is to deliver fluids or medications while minimizing post-procedure needle-stick injuries through an integrated, single-handed activation mechanism.
This device is intended for single-use in clinical settings, including general hospitals, and is supplied sterile. The needle features a pivoting shield that activates upon withdrawal from the patient, reducing exposure risk. Authorized under FDA 510(k) clearance (K161170) as substantially equivalent to predicate devices, it adheres to regulatory standards for hypodermic needles in the United States.
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 Eclipse™ Needle, BD Eclipse Hypodermic Needle - vitalsupplyco.com, BD (company) - Wikipedia, BECTON, DICKINSON AND COMPANY 303304 BD Eclipse Needle - RevMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161170 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K161170 24 fields · synced Sep 18, 2026