Cleared Traditional

K112056 - ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL

K112056 is an FDA 510(k) clearance for ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, manufactured by Ethicon Endo-Surgery, LLC. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K112056 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
153d
Days
Class 2
Risk

K112056 is an FDA 510(k) clearance for the ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 EN.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on December 19, 2011 after a review of 153 days - an extended review 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. 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 Ethicon Endo-Surgery, LLC devices

FDA 510(k) Submission Details - K112056

510(k) Number K112056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2011
Decision Date December 19, 2011
Days to Decision 153 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
38d slower than avg
Panel avg: 115d · This submission: 153d
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 223
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K112056.
INSORB ABSORBALBE STAPLE
K120373 · Incisive Surgical, Inc. · Mar 2012
DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS
K120258 · Covidien, Formerly US Surgical A Divison of Tyco H · Feb 2012
AMID STAPLER
K120268 · Safestich Medical, LLC · Feb 2012
ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
K111825 · Covidien, Formerly US Surgical A Divison of Tyco H · Oct 2011
VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
K111195 · Ethicon Endo-Surgery, Inc. · Aug 2011
IMESH TACKER
K110728 · Easylap , Ltd. · Jun 2011