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FDA 510(k)

TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM

K-Number: K120437 · 2012-04-26

ApplicantBiolitec Sia (Latvia)
Decision Date2012-04-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec Sia (Latvia). It received FDA 510(k) clearance on 2012-04-26 under 510(k) number K120437. 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 TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM?

TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-26. The listed applicant is Biolitec Sia (Latvia). The 510(k) number is K120437.

When did TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM receive FDA 510(k) clearance?

TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM received FDA 510(k) clearance on 2012-04-26, under 510(k) number K120437.

Who is the listed applicant for TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM?

The FDA 510(k) record lists Biolitec Sia (Latvia) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM?

The FDA product code for TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM 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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