Cleared Special

SILS STITCH ENDOSCOPIC SUTURING DEVICE (K090419) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K090419 · Covidien Lp, Formerly Registered AS United States · Gastroenterology & Urology device
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Mar 2009
Decision
19d
Days
Class 2
Risk

K090419 is an FDA 510(k) clearance for the SILS STITCH ENDOSCOPIC SUTURING DEVICE. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Covidien Lp, Formerly Registered AS United States (North Haven, US). The FDA issued a Cleared decision on March 9, 2009 after a review of 19 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 Covidien Lp, Formerly Registered AS United States devices

Submission Details

510(k) Number K090419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2009
Decision Date March 09, 2009
Days to Decision 19 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 130d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K090419.
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endomina system
K211309 · Endo Tools Therapeutics S.A. · Dec 2021