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FDA 510(k)

CELON ENT SYSTEM

K-Number: K032838 · 2003-09-26

ApplicantCelon AG Medical Instruments
Decision Date2003-09-26
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CELON ENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Celon AG Medical Instruments. It received FDA 510(k) clearance on 2003-09-26 under 510(k) number K032838. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELON ENT SYSTEM?

CELON ENT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-26. The listed applicant is Celon AG Medical Instruments. The 510(k) number is K032838.

When did CELON ENT SYSTEM receive FDA 510(k) clearance?

CELON ENT SYSTEM received FDA 510(k) clearance on 2003-09-26, under 510(k) number K032838.

Who is the listed applicant for CELON ENT SYSTEM?

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

What is the FDA product code for CELON ENT SYSTEM?

The FDA product code for CELON ENT SYSTEM is GEI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Celon AG Medical Instruments as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073207OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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