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FDA 510(k)

APOGEE ELITE

K-Number: K034030 · 2004-02-09

ApplicantCynosure, Inc.
Decision Date2004-02-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

APOGEE ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure, Inc.. It received FDA 510(k) clearance on 2004-02-09 under 510(k) number K034030. 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 APOGEE ELITE?

APOGEE ELITE is a medical device that received FDA 510(k) clearance on 2004-02-09. The listed applicant is Cynosure, Inc.. The 510(k) number is K034030.

When did APOGEE ELITE receive FDA 510(k) clearance?

APOGEE ELITE received FDA 510(k) clearance on 2004-02-09, under 510(k) number K034030.

Who is the listed applicant for APOGEE ELITE?

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 APOGEE ELITE?

The FDA product code for APOGEE ELITE 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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