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FDA 510(k)

ADVANCIS ACTIVON TUBE

K-Number: K101114 · 2011-07-26

ApplicantAdvancis Medical
Decision Date2011-07-26
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ADVANCIS ACTIVON TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Advancis Medical. It received FDA 510(k) clearance on 2011-07-26 under 510(k) number K101114. 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 ADVANCIS ACTIVON TUBE?

ADVANCIS ACTIVON TUBE is a medical device that received FDA 510(k) clearance on 2011-07-26. The listed applicant is Advancis Medical. The 510(k) number is K101114.

When did ADVANCIS ACTIVON TUBE receive FDA 510(k) clearance?

ADVANCIS ACTIVON TUBE received FDA 510(k) clearance on 2011-07-26, under 510(k) number K101114.

Who is the listed applicant for ADVANCIS ACTIVON TUBE?

The FDA 510(k) record lists Advancis Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVANCIS ACTIVON TUBE?

The FDA product code for ADVANCIS ACTIVON TUBE is FRO. This falls under the Anesthesiology category.

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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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