Cleared Special

K131705 - ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY

K131705 is an FDA 510(k) clearance for ENDO GIA RADIAL RELOAD WITH TRI-STAPLE ..., manufactured by Covidien, Formerly US Surgical A Divison of Tyco H. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 20-day FDA review.

K131705 · Covidien, Formerly US Surgical A Divison of Tyco H · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
20d
Days
Class 2
Risk

K131705 is an FDA 510(k) clearance for the ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien, Formerly US Surgical A Divison of Tyco H (North Haven, US). The FDA issued a Cleared decision on July 1, 2013 after a review of 20 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, Formerly US Surgical A Divison of Tyco H devices

FDA 510(k) Submission Details - K131705

510(k) Number K131705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2013
Decision Date July 01, 2013
Days to Decision 20 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

GDW Device Classification - Class 2, Special Controls

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 184
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K131705.
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
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