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FDA 510(k)

ENDOVASCULAR LAER VEIN SYSTEM KIT

K-Number: K101712 · 2010-10-27

ApplicantBiolitec, Inc.
Decision Date2010-10-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOVASCULAR LAER VEIN SYSTEM KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biolitec, Inc.. It received FDA 510(k) clearance on 2010-10-27 under 510(k) number K101712. 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 ENDOVASCULAR LAER VEIN SYSTEM KIT?

ENDOVASCULAR LAER VEIN SYSTEM KIT is a medical device that received FDA 510(k) clearance on 2010-10-27. The listed applicant is Biolitec, Inc.. The 510(k) number is K101712.

When did ENDOVASCULAR LAER VEIN SYSTEM KIT receive FDA 510(k) clearance?

ENDOVASCULAR LAER VEIN SYSTEM KIT received FDA 510(k) clearance on 2010-10-27, under 510(k) number K101712.

Who is the listed applicant for ENDOVASCULAR LAER VEIN SYSTEM KIT?

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

What is the FDA product code for ENDOVASCULAR LAER VEIN SYSTEM KIT?

The FDA product code for ENDOVASCULAR LAER VEIN SYSTEM KIT 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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