Cleared Special

K123109 - ABSORBATACK 5MM SINGLE USE ABSORBABLE F...

K123109 is the FDA 510(k) clearance for ABSORBATACK 5MM SINGLE USE ABSORBABLE F... by Covidien. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Special 510(k) pathway after a 19-day FDA review.

K123109 · Covidien · General & Plastic Surgery device
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Oct 2012
Decision
19d
Days
Class 2
Risk

K123109 is an FDA 510(k) clearance for the ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on October 23, 2012 after a review of 19 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 K123109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2012
Decision Date October 23, 2012
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
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 K123109.
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
K130653 · Ethicon Endo-Surgery, LLC · Mar 2013
ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE
K123114 · Ethicon, Inc. · Feb 2013
PERMASORB DISPOSABLE FIXATION DEVICE
K123718 · C.R. Bard, Inc. · Jan 2013
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
K121600 · Ethicon Endo-Surgery, LLC · Jul 2012
ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL
K112056 · Ethicon Endo-Surgery, LLC · Dec 2011
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
K111195 · Ethicon Endo-Surgery, Inc. · Aug 2011