Cleared Special

K103263 - ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY

K103263 is an FDA 510(k) clearance for ENDO GIA SINGLEUSE DUET TRS RELOAD WITH..., 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 18-day FDA review.

K103263 · 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
Nov 2010
Decision
18d
Days
Class 2
Risk

K103263 is an FDA 510(k) clearance for the ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE 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 November 22, 2010 after a review of 18 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 - K103263

510(k) Number K103263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2010
Decision Date November 22, 2010
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
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 K103263.
REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
K103672 · Ethicon Endo-Surgery, LLC · Apr 2011
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K110385 · Ethicon Endo-Surgery, Inc. · Mar 2011
REUSABLE LINEAR STAPLER HANDLE
K110049 · Ethicon Endo-Surgery, LLC · Feb 2011
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
K102632 · Ethicon Endo-Surgery, Inc. · Oct 2010
COVIDIEN ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K102291 · Covidien · Sep 2010
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
K093845 · Ethicon, Inc. · Apr 2010