Cleared Traditional

K073644 - ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K073644 · Endogastric Solutions, Inc. · Gastroenterology & Urology device
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Jun 2008
Decision
184d
Days
Class 2
Risk

K073644 is an FDA 510(k) clearance for the ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Endogastric Solutions, Inc. (Redmond, US). The FDA issued a Cleared decision on June 27, 2008 after a review of 184 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Endogastric Solutions, Inc. devices

Submission Details

510(k) Number K073644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date June 27, 2008
Days to Decision 184 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 130d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCW Endoscopic Tissue Approximation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Aid In Endoscopically Placing Sutures, Staples, Clips, And Other Fastening Tools Through Tissue.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 69
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