Cleared Traditional

ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES (K062875) - FDA 510(k) Clearance

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

K062875 · Endogastric Solutions, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
164d
Days
Class 2
Risk

K062875 is an FDA 510(k) clearance for the ENDOGASTRIC 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 March 9, 2007 after a review of 164 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 K062875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2006
Decision Date March 09, 2007
Days to Decision 164 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
34d slower than avg
Panel avg: 130d · This submission: 164d
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 33
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K062875.
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · Teleflexmedical, Inc. · Feb 2018
AUTOSUTURE PROTACK
K090470 · Covidien · May 2009
OPUS SMARTSTITCH SUTURE DEVICE
K070671 · Arthrocare Corp. · Apr 2007
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K062244 · Arthrocare Corp. · Oct 2006
ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
K061770 · Ethicon Endo-Surgery, Inc. · Sep 2006
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269 · Ethicon Endo-Surgery, Inc. · Dec 2003