Identifiers
- 510(k) Number
- K092016 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 Super-Fine Pen Needle is a sterile, single-use hypodermic needle designed for subcutaneous insulin delivery. It is engineered to facilitate the administration of insulin via pen devices.
This device is supplied as a 31 gauge, 5mm needle under catalog number PNC-100. It has received FDA 510(k) clearance for 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: Superfine • Insulin Pen Needles - STAT Medical Devices, Micro • 31g/5mm - statmedicaldevices.com, SUPER-FINE PEN NEEDLE (K092016) — 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 | K092016 | Class II | Active |
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Manufacturer
- Manufacturer
- Stat Medical Devices, Inc.
Sources (1)
- FDA 510(k) K092016 24 fields · synced Sep 25, 2026