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FDA 510(k)

VARI-LASE WIREFIBER LASER FIBER

K-Number: K113140 · 2011-12-22

ApplicantVascular Solutions, Inc.
Decision Date2011-12-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VARI-LASE WIREFIBER LASER FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K113140. 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 VARI-LASE WIREFIBER LASER FIBER?

VARI-LASE WIREFIBER LASER FIBER is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K113140.

When did VARI-LASE WIREFIBER LASER FIBER receive FDA 510(k) clearance?

VARI-LASE WIREFIBER LASER FIBER received FDA 510(k) clearance on 2011-12-22, under 510(k) number K113140.

Who is the listed applicant for VARI-LASE WIREFIBER LASER FIBER?

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

What is the FDA product code for VARI-LASE WIREFIBER LASER FIBER?

The FDA product code for VARI-LASE WIREFIBER LASER FIBER 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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