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NovoFine Autocover 30G x 8MM

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050106

by Novo Nordisk, Inc.

Identifiers

510(k) Number
K050106 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 NovoFine Autocover 30G x 8mm is a disposable safety needle designed for subcutaneous injections. It features an automatic safety shield that conceals the needle after use, reducing the risk of needle-stick injuries and potentially alleviating needle anxiety in patients.

This device is supplied sterile, non-toxic, and non-pyrogenic, intended for single-use only. Compatible with most insulin delivery devices, it is regulated under FDA 510(k) clearance (K050106) and is classified under the product code FMI. Storage should follow manufacturer guidelines to maintain sterility and integrity.

Frequently asked questions

What is the NovoFine Autocover 30G x 8mm designed to reduce during use, and how does it achieve this?

The NovoFine Autocover 30G x 8mm is specifically designed to reduce the risk of needle-stick injuries and patient anxiety related to needles. It achieves this through an automatic safety shield that securely covers the needle immediately after use, effectively concealing the sharp tip.

Is this needle reusable, or is it intended for single-use only? What does that mean for safety?

The NovoFine Autocover 30G x 8mm is explicitly intended for single-use only, meaning it should not be reused after one injection. This ensures safety by preventing potential contamination, reducing the risk of infection, and maintaining sterility, as it is supplied in a sterile, non-pyrogenic package.

What types of insulin delivery devices is this needle compatible with, and how should it be stored?

This needle is designed to be compatible with most insulin delivery devices, making it versatile for patients using automated or manual systems. For storage, it should follow the manufacturer’s guidelines to preserve sterility and integrity—typically, this means keeping it in its original packaging until use and avoiding exposure to moisture or extreme temperatures.

How do I know this needle is safe to use, and what does the term *non-pyrogenic* mean in this context?

The NovoFine Autocover is labeled as sterile, non-toxic, and non-pyrogenic, meaning it won’t introduce harmful substances or fever-inducing contaminants into the body. *Non-pyrogenic* ensures it won’t trigger an adverse immune response, making it safer for subcutaneous injections like insulin delivery.

What gauge and length does this needle have, and why might those specifications matter for patients?

This needle is a 30G (gauge) x 8mm (length), which is a common size for subcutaneous injections like insulin. The smaller gauge (30G) reduces discomfort, while the 8mm length ensures it reaches the appropriate tissue layer for effective drug absorption without penetrating too deeply.

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: NovoFine Autocover - Novo Nordisk, Novo Nordisk novofine Autocover 30G User Manual, Novo Nordisk novofine Autocover 30G User Manual, Novo Nordisk novofine Autocover 30G User Manual | 1 page, PDF 30 gauge x 1/3" (8 mm) Sterile, Non-toxic, Non-pyrogenic, Introduction

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Novo Nordisk, Inc.

Sources (1)

  • FDA 510(k) K050106 24 fields · synced Sep 19, 2026