Clickfine Pen Needle
FDA 510(k)Class II (US FDA 510(k))
by Ypsomed AG
Identifiers
- 510(k) Number
- K102108 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 Clickfine Pen Needle is a medical device designed for subcutaneous injections. It features an innovative 6-bevel technology with four bevels on the upper side and two on the lower side, creating a pointed and sharper needle tip for gentle and smooth injections.
This device is supplied in various sizes and is intended for single-use applications. It has received FDA 510(k) clearance as substantially equivalent under product code FMI, with the authorization number K102108. The device is manufactured by Ypsomed AG and meets all acceptance criteria for performance requirements.
Frequently asked questions
What is the Clickfine Pen Needle used for?
The Clickfine Pen Needle is designed specifically for subcutaneous injections. Its innovative 6-bevel technology creates a pointed and sharper needle tip, ensuring gentle and smooth injections for patients requiring medication delivery.
Is the Clickfine Pen Needle reusable or single-use?
The Clickfine Pen Needle is intended for single-use applications only. After each use, the needle should be properly disposed of to ensure safety and prevent contamination or needle stick injuries.
What sizes are available for the Clickfine Pen Needle?
The Clickfine Pen Needle is supplied in various sizes to accommodate different patient needs and injection requirements. However, specific gauge lengths are not detailed in the provided information.
What regulatory approval does the Clickfine Pen Needle have?
The Clickfine Pen Needle has received FDA 510(k) clearance as substantially equivalent under product code FMI, with authorization number K102108. This clearance indicates it meets the FDA's requirements for safety and effectiveness.
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: Clickfine DiamondTip - my clickfine - distributoren.ypsomed.com, Ypsomed AG FDA 510(k) General Hospital Products - Latest 2025, PDF 510k Special: Clickfine pen needle - Food and Drug Administration, CLICKFINE PEN NEEDLE (K102108) — 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 | K102108 | Class II | Active |
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Manufacturer
- Manufacturer
- Ypsomed AG
Sources (1)
- FDA 510(k) K102108 24 fields · synced Sep 26, 2026