FDA 510(k)

DURAFIBER AG

K-Number: K103793 · 2011-05-02

Decision Date2011-05-02

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

DURAFIBER AG is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2011-05-02 under 510(k) number K103793. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURAFIBER AG?

DURAFIBER AG is a medical device that received FDA 510(k) clearance on 2011-05-02. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K103793.

When did DURAFIBER AG receive FDA 510(k) clearance?

DURAFIBER AG received FDA 510(k) clearance on 2011-05-02, under 510(k) number K103793.

Who is the listed applicant for DURAFIBER AG?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURAFIBER AG?

The FDA product code for DURAFIBER AG is FRO. This falls under the Anesthesiology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.