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FDA 510(k)

MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES

K-Number: K980389 · 1998-07-29

ApplicantCeram Optec, Inc.
Decision Date1998-07-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES 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 1998-07-29 under 510(k) number K980389. 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 MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES?

MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Ceram Optec, Inc.. The 510(k) number is K980389.

When did MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES receive FDA 510(k) clearance?

MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES received FDA 510(k) clearance on 1998-07-29, under 510(k) number K980389.

Who is the listed applicant for MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES?

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 MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES?

The FDA product code for MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES is GEX. This falls under the Gastroenterology category.

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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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