Cleared Special

K181141 - OverStitch Endoscopic Suturing System and Accessories

K181141 is an FDA 510(k) clearance for OverStitch Endoscopic Suturing System a..., manufactured by Apollo Endosurgery. The device is a Class 2 Gastroenterology & Urology device with product code OCW cleared through the Special 510(k) pathway after a 57-day FDA review.

K181141 · Apollo Endosurgery · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Jun 2018
Decision
57d
Days
Class 2
Risk

K181141 is an FDA 510(k) clearance for the OverStitch Endoscopic Suturing System and Accessories. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Apollo Endosurgery (Austin, US). The FDA issued a Cleared decision on June 27, 2018 after a review of 57 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 Apollo Endosurgery devices

FDA 510(k) Submission Details - K181141

510(k) Number K181141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2018
Decision Date June 27, 2018
Days to Decision 57 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
74d faster than avg
Panel avg: 131d · This submission: 57d
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 50
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K181141.
OverStitch Sx Endoscopic Suturing System
K210266 · Apollo Endosurgery, Inc. · Mar 2021
AbClose - Port Site Closure Device
K193652 · Medeon Biodesign, Inc. · Mar 2020
OverStitch 2-0 Polypropylene Suture
K191439 · Apollo Endosurgery · Aug 2019
MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle
K172775 · Teleflexmedical, Inc. · Feb 2018
CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
K172666 · Sutureease, Inc. · Dec 2017
OverStitch SX Endoscopic Suturing System (ESS)
K171886 · Apollo Endosurgery, Inc. · Nov 2017