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FDA 510(k)

DURAFIBER Ag

K-Number: K161289 · 2016-08-03

ApplicantSmith & Nephew Medical Limited
Decision Date2016-08-03
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 Medical Limited. It received FDA 510(k) clearance on 2016-08-03 under 510(k) number K161289. 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 2016-08-03. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K161289.

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

DURAFIBER Ag received FDA 510(k) clearance on 2016-08-03, under 510(k) number K161289.

Who is the listed applicant for DURAFIBER Ag?

The FDA 510(k) record lists Smith & Nephew Medical Limited 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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Related Devices (Code: FRO)

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Official Source

View on FDA Database →

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

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