BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162081 FDA 510(k)
- FDA Product Code
- FMF 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 BD 1 mL Luer-Lok Hypodermic Syringe is a hypodermic syringe designed for precise drug administration. It features a Luer-Lok connection for secure attachment to needles, ensuring leak-proof delivery and ease of use in clinical settings. Available in standard and insulin variants, it supports accurate dosing for subcutaneous, intramuscular, or intravenous applications.
This device is supplied sterile and intended for single-use only, adhering to standard medical syringe regulations. It is classified under product code FMF and holds FDA 510(k) clearance (K162081) as substantially equivalent to a predicate device. Compatible with BD Hypodermic Needles or BD Eclipse Hypodermic Needles, it is manufactured by Becton, Dickinson and Company and distributed in sterile packaging for immediate clinical use.
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: 1 mL BD Luer-Lok™ Syringe only - 309628 | BD, 1 mL BD Luer-Lok™ Syringe 309628 | Sterile, Single-Use Precision Syringe, BD Disposable Syringes with Luer-Lok Tips 1 mL | Buy Online | BD ..., BD (company) - Wikipedia, BD 1mL Luer-Lok Disposable Syringe ONLY 100/Box (309628)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162081 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K162081 24 fields · synced Sep 18, 2026