Cleared Special

K133762 - ENDO GIA(TM) EXTRA LONG ADAPTER

K133762 is the FDA 510(k) clearance for ENDO GIA(TM) EXTRA LONG ADAPTER by Covidien, LLC. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Special 510(k) pathway after a 28-day FDA review.

K133762 · Covidien, LLC · General & Plastic Surgery device
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Jan 2014
Decision
28d
Days
Class 2
Risk

K133762 is an FDA 510(k) clearance for the ENDO GIA(TM) EXTRA LONG ADAPTER. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien, LLC (North Haven, US). The FDA issued a Cleared decision on January 8, 2014 after a review of 28 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, LLC devices

Submission Details

510(k) Number K133762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2013
Decision Date January 08, 2014
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 K133762.
ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
K140560 · Ethicon Endo-Surgery, LLC · Apr 2014
RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
K140609 · Covidien · Apr 2014
ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY
K133938 · Covidien · Jan 2014
OPTIFIX ABSORBABLE FIXATION SYSTEM
K132134 · C.R. Bard, Inc. · Dec 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K132493 · Covidien, LLC · Oct 2013
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
K131663 · Ethicon Endo-Surgery, LLC · Oct 2013