Identifiers
- 510(k) Number
- K220614 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)
MEDOJECT fine Pen Needles are hypodermic, single-lumen needles classified under product code FMI. They are designed for use with insulin pens and feature a precision lancet point with silicone treatment for smooth penetration.
These needles are supplied sterile and intended for single-use. They are compatible with most type A insulin pens and have received FDA 510(k) clearance (K220614) as substantially equivalent to the UltiCare Disposable Pen Needle.
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: MEDOJECT Fine Insulin Pen needles - T-Injecta, K220614 - MEDOJECT fine Pen Needles | FDA 510 (k), MEDOJECT fine Pen Needles (K220614) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220614 | Class II | Active |
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Manufacturer
- Manufacturer
- Chirana T. Injecta
Sources (1)
- FDA 510(k) K220614 24 fields · synced Sep 24, 2026