FDA 510(k)

ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE

K-Number: K090084 · 2009-03-06

Decision Date2009-03-06

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2009-03-06 under 510(k) number K090084. 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 ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE?

ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE is a medical device that received FDA 510(k) clearance on 2009-03-06. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K090084.

When did ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE receive FDA 510(k) clearance?

ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE received FDA 510(k) clearance on 2009-03-06, under 510(k) number K090084.

Who is the listed applicant for ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE?

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

What is the FDA product code for ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE?

The FDA product code for ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE 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.