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FDA 510(k)

RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM

K-Number: K112442 · 2011-09-30

ApplicantBiolitec Medical Devices, Inc.
Decision Date2011-09-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM 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 2011-09-30 under 510(k) number K112442. 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 RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM?

RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-30. The listed applicant is Biolitec Medical Devices, Inc.. The 510(k) number is K112442.

When did RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM receive FDA 510(k) clearance?

RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM received FDA 510(k) clearance on 2011-09-30, under 510(k) number K112442.

Who is the listed applicant for RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM?

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 RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM?

The FDA product code for RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Biolitec Medical Devices, Inc. as applicant

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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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