Cleared Traditional

K160117 - AbClose - Port Site Closure Device

K160117 is an FDA 510(k) clearance for AbClose - Port Site Closure Device, manufactured by Medeon Biodesign, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OCW cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K160117 · Medeon Biodesign, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
234d
Days
Class 2
Risk

K160117 is an FDA 510(k) clearance for the AbClose - Port Site Closure Device. Classified as Endoscopic Tissue Approximation Device (product code OCW), Class II - Special Controls.

Submitted by Medeon Biodesign, Inc. (Taipei, TW). The FDA issued a Cleared decision on September 9, 2016 after a review of 234 days - an extended review cycle.

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 Medeon Biodesign, Inc. devices

FDA 510(k) Submission Details - K160117

510(k) Number K160117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date September 09, 2016
Days to Decision 234 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
119d slower than avg
Panel avg: 115d · This submission: 234d
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 General & Plastic Surgery 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 K160117.
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
Miret Grasper, Alligator, Miret Grasper, Maryland
K160149 · Miret Surgical, Inc. · Aug 2016
MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
K132232 · Minilap Technologies · Dec 2013
WECK EFX ENDO FASCIAL CLOSURE SYSTEM
K132362 · Teleflexmedical, Inc. · Oct 2013