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FDA 510(k)

MEGABEAM FIBER OPTIC DELIVERY SYSTEM

K-Number: K946336 · 1995-02-10

ApplicantHogan & Hartson
Decision Date1995-02-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEGABEAM FIBER OPTIC DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hogan & Hartson. It received FDA 510(k) clearance on 1995-02-10 under 510(k) number K946336. 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 FIBER OPTIC DELIVERY SYSTEM?

MEGABEAM FIBER OPTIC DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-10. The listed applicant is Hogan & Hartson. The 510(k) number is K946336.

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

MEGABEAM FIBER OPTIC DELIVERY SYSTEM received FDA 510(k) clearance on 1995-02-10, under 510(k) number K946336.

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

The FDA 510(k) record lists Hogan & Hartson as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for 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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