Cleared Traditional

K073671 - PLICATOR GSX SUTURING SYSTEM

K073671 is an FDA 510(k) clearance for PLICATOR GSX SUTURING SYSTEM, manufactured by Ndo Surgical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K073671 · Ndo Surgical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
90d
Days
Class 2
Risk

K073671 is an FDA 510(k) clearance for the PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX.... Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Ndo Surgical, Inc. (Mansfield, US). The FDA issued a Cleared decision on March 26, 2008 after a review of 90 days - within the typical 510(k) review window.

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 Ndo Surgical, Inc. devices

FDA 510(k) Submission Details - K073671

510(k) Number K073671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2007
Decision Date March 26, 2008
Days to Decision 90 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
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 38
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K073671.
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · Teleflexmedical, Inc. · Feb 2018
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K090470 · Covidien · May 2009
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K070151 · Ethicon Endo-Surgery, LLC · Aug 2007
OPUS SMARTSTITCH SUTURE DEVICE
K070671 · Arthrocare Corp. · Apr 2007
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR
K062244 · Arthrocare Corp. · Oct 2006