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FDA 510(k)

MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE

K-Number: K113709 · 2012-01-20

ApplicantBiolitec Medical Devices, Inc.
Decision Date2012-01-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec Medical Devices, Inc.. It received FDA 510(k) clearance on 2012-01-20 under 510(k) number K113709. 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 WITH ADDITIONAL TIPS & HANDPIECE?

MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE is a medical device that received FDA 510(k) clearance on 2012-01-20. The listed applicant is Biolitec Medical Devices, Inc.. The 510(k) number is K113709.

When did MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE receive FDA 510(k) clearance?

MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE received FDA 510(k) clearance on 2012-01-20, under 510(k) number K113709.

Who is the listed applicant for MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE?

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

What is the FDA product code for MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE?

The FDA product code for MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE 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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