Carefine Pen Needle With Quintapoint And Superpoint
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140568 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 Carefine Pen Needle With Quintapoint And Superpoint is a pen needle device intended for use with a pen injector device for the subcutaneous injection of insulin. It features two point bevel geometries: QuintaPoint™ (5-bevel) and SuperPoint™, along with colored inner needle shields for length identification and silicone-based lubrication to aid ease of injection and septum penetration.
It is used by patients, caregivers, and clinicians in home or clinical settings. The device is supplied as a sterile, single-use product. Regulatory authorization is based on FDA 510(k) clearance (K140568) under product code FMI.
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: Carefine Pen Needle With Quintapoint and Superpoint (K140568) — Fda 510 ..., Carefine Pen Needle With Quintapoint and Superpoint, Carefine Pen Needle Family Including Quintapoint and Superpoint ..., CareFine with Quintapoint Pen Needles - 5mm x 32G Medical Device ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140568 | Class II | Active |
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Manufacturer
- Manufacturer
- Facet Technologies, LLC
Sources (1)
- FDA 510(k) K140568 24 fields · synced Sep 25, 2026