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FDA 510(k)

ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE

K-Number: K011591 · 2002-07-19

ApplicantWilson-Cook Medical, Inc.
Decision Date2002-07-19
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2002-07-19 under 510(k) number K011591. 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 ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE?

ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE is a medical device that received FDA 510(k) clearance on 2002-07-19. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K011591.

When did ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE receive FDA 510(k) clearance?

ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE received FDA 510(k) clearance on 2002-07-19, under 510(k) number K011591.

Who is the listed applicant for ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE?

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

What is the FDA product code for ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE?

The FDA product code for ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE 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.

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