Cleared Special

K090419 - SILS STITCH ENDOSCOPIC SUTURING DEVICE

K090419 is an FDA 510(k) clearance for SILS STITCH ENDOSCOPIC SUTURING DEVICE, manufactured by Covidien Lp, Formerly Registered AS United States. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Special 510(k) pathway after a 19-day FDA review.

K090419 · Covidien Lp, Formerly Registered AS United States · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K090419

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.

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 K090419.
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · Teleflexmedical, Inc. · Feb 2018
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
K132362 · Teleflexmedical, Inc. · Oct 2013
AUTOSUTURE PROTACK
K090470 · Covidien · May 2009
INSCOPE TISSUE ANCHORS, KNOTTING ELEMENTS AND TISSUE ANCHOR AND KNOTTING ELEMENT APPLIER
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