Cleared Special

K140609 - RELIATACK ARTICULATING RELOADABLE FIXAT...

K140609 is the FDA 510(k) clearance for RELIATACK ARTICULATING RELOADABLE FIXAT... by Covidien. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Special 510(k) pathway after a 30-day FDA review.

K140609 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Apr 2014
Decision
30d
Days
Class 2
Risk

K140609 is an FDA 510(k) clearance for the RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSO.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on April 9, 2014 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery 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 devices

Submission Details

510(k) Number K140609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2014
Decision Date April 09, 2014
Days to Decision 30 days
Submission Type Special
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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 152
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K140609.
CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners
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K140560 · Ethicon Endo-Surgery, LLC · Apr 2014
ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY
K133938 · Covidien · Jan 2014
ENDO GIA(TM) EXTRA LONG ADAPTER
K133762 · Covidien, LLC · Jan 2014
OPTIFIX ABSORBABLE FIXATION SYSTEM
K132134 · C.R. Bard, Inc. · Dec 2013