Cleared Traditional

K111825 - ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS

K111825 is an FDA 510(k) clearance for ENDO GIA(TM) STAPLERS, 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 Traditional 510(k) pathway after a 119-day FDA review.

K111825 · 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
Oct 2011
Decision
119d
Days
Class 2
Risk

K111825 is an FDA 510(k) clearance for the ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM).... 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 October 25, 2011 after a review of 119 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Covidien, Formerly US Surgical A Divison of Tyco H devices

FDA 510(k) Submission Details - K111825

510(k) Number K111825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2011
Decision Date October 25, 2011
Days to Decision 119 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K111825.
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
K123109 · Covidien · Oct 2012
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
ENDOPATH ETS 35MM ENDOSCOPIC LINEAR CUTTER AND RELOADS, AND ETS-FLEX 35MM ENDOSCOPIC ARTICULATING LINEAR CUTTER AND RELO
K111111 · Ethicon Endo-Surgery, LLC · Jun 2011
SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM
K111153 · C.R. Bard, Inc. · May 2011