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FDA 510(k)

AFFIRM CO2 AND AFFIRM CO2 HP

K-Number: K081424 · 2009-03-19

ApplicantCynosure, Inc.
Decision Date2009-03-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AFFIRM CO2 AND AFFIRM CO2 HP is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 2009-03-19 under 510(k) number K081424. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFFIRM CO2 AND AFFIRM CO2 HP?

AFFIRM CO2 AND AFFIRM CO2 HP is a medical device that received FDA 510(k) clearance on 2009-03-19. The listed applicant is Cynosure, Inc.. The 510(k) number is K081424.

When did AFFIRM CO2 AND AFFIRM CO2 HP receive FDA 510(k) clearance?

AFFIRM CO2 AND AFFIRM CO2 HP received FDA 510(k) clearance on 2009-03-19, under 510(k) number K081424.

Who is the listed applicant for AFFIRM CO2 AND AFFIRM CO2 HP?

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

What is the FDA product code for AFFIRM CO2 AND AFFIRM CO2 HP?

The FDA product code for AFFIRM CO2 AND AFFIRM CO2 HP is GEX. This falls under the Gastroenterology 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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