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FDA 510(k)

ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES

K-Number: K062875 · 2007-03-09

ApplicantEndogastric Solutions, Inc.
Decision Date2007-03-09
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES 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 2007-03-09 under 510(k) number K062875. 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 STOMAPHYX DEVICE AND ACCESSORIES?

ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2007-03-09. The listed applicant is Endogastric Solutions, Inc.. The 510(k) number is K062875.

When did ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES receive FDA 510(k) clearance?

ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES received FDA 510(k) clearance on 2007-03-09, under 510(k) number K062875.

Who is the listed applicant for ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES?

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 STOMAPHYX DEVICE AND ACCESSORIES?

The FDA product code for ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES is OCW.

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Related Devices (Code: OCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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