FDA 510(k)

ENDOMAXX FULLY COVERED ESOPHAGEAL STENT

K-Number: K111611 · 2011-07-29

Decision Date2011-07-29

Product CodeESW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ENDOMAXX FULLY COVERED ESOPHAGEAL STENT 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 2011-07-29 under 510(k) number K111611. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOMAXX FULLY COVERED ESOPHAGEAL STENT?

ENDOMAXX FULLY COVERED ESOPHAGEAL STENT is a medical device that received FDA 510(k) clearance on 2011-07-29. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K111611.

When did ENDOMAXX FULLY COVERED ESOPHAGEAL STENT receive FDA 510(k) clearance?

ENDOMAXX FULLY COVERED ESOPHAGEAL STENT received FDA 510(k) clearance on 2011-07-29, under 510(k) number K111611.

Who is the listed applicant for ENDOMAXX FULLY COVERED ESOPHAGEAL STENT?

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 ENDOMAXX FULLY COVERED ESOPHAGEAL STENT?

The FDA product code for ENDOMAXX FULLY COVERED ESOPHAGEAL STENT is ESW.

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Related Devices (Code: ESW)

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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.