Cleared Traditional

K191439 - OverStitch 2-0 Polypropylene Suture

K191439 is the FDA 510(k) clearance for OverStitch 2-0 Polypropylene Suture by Apollo Endosurgery. It is a Class 2 General & Plastic Surgery device (product code OCW) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K191439 · Apollo Endosurgery · General & Plastic Surgery device
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Aug 2019
Decision
91d
Days
Class 2
Risk

K191439 is an FDA 510(k) clearance for the OverStitch 2-0 Polypropylene Suture. 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 August 29, 2019 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Apollo Endosurgery devices

Submission Details

510(k) Number K191439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2019
Decision Date August 29, 2019
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OCW Endoscopic Tissue Approximation Device

All 36
Devices cleared under the same product code (OCW) and FDA review panel - the closest regulatory comparables to K191439.
Su2ura Approximation Device
K201744 · Anchora Medical, Ltd. · Jun 2021
OverStitch Sx Endoscopic Suturing System
K210266 · Apollo Endosurgery, Inc. · Mar 2021
AbClose - Port Site Closure Device
K193652 · Medeon Biodesign, Inc. · Mar 2020
OverStitch Endoscopic Suturing System and Accessories
K181141 · Apollo Endosurgery · Jun 2018
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