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FDA 510(k)

ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER

K-Number: K091832 · 2009-07-22

ApplicantEndogastric Solutions, Inc.
Decision Date2009-07-22
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER is the device name listed in this FDA 510(k) record. The listed applicant is Endogastric Solutions, Inc.. It received FDA 510(k) clearance on 2009-07-22 under 510(k) number K091832. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER?

ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER is a medical device that received FDA 510(k) clearance on 2009-07-22. The listed applicant is Endogastric Solutions, Inc.. The 510(k) number is K091832.

When did ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER receive FDA 510(k) clearance?

ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER received FDA 510(k) clearance on 2009-07-22, under 510(k) number K091832.

Who is the listed applicant for ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER?

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

What is the FDA product code for ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER?

The FDA product code for ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER is OCW.

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Related Devices (Code: OCW)

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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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