Cleared Special

K091832 - ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER

K091832 is an FDA 510(k) clearance for ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM ..., manufactured by Endogastric Solutions, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Special 510(k) pathway after a 30-day FDA review.

K091832 · Endogastric Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
30d
Days
Class 2
Risk

K091832 is an FDA 510(k) clearance for the ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER. 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 July 22, 2009 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Endogastric Solutions, Inc. devices

FDA 510(k) Submission Details - K091832

510(k) Number K091832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2009
Decision Date July 22, 2009
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

OCW Device Classification - Class 2, Special Controls

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 67
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K091832.
AXIOM FASCIAL CLOSURE SYSTEM
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AUTOSUTURE PROTACK
K090470 · Covidien · May 2009
SILS STITCH ENDOSCOPIC SUTURING DEVICE
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K082659 · Covidien Lp, Formerly Registered AS United States · Sep 2008