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FDA 510(k)

REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM

K-Number: K980838 · 1998-06-02

ApplicantCeram Optec, Inc.
Decision Date1998-06-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ceram Optec, Inc.. It received FDA 510(k) clearance on 1998-06-02 under 510(k) number K980838. 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 REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM?

REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-02. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K980838.

When did REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM receive FDA 510(k) clearance?

REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM received FDA 510(k) clearance on 1998-06-02, under 510(k) number K980838.

Who is the listed applicant for REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM?

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

What is the FDA product code for REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM?

The FDA product code for REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM 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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