Cleared Traditional

K131663 - ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK

K131663 is an FDA 510(k) clearance for ECHELON 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 133-day FDA review.

K131663 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
133d
Days
Class 2
Risk

K131663 is an FDA 510(k) clearance for the ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK. 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 October 18, 2013 after a review of 133 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.

FDA 510(k) Submission Details - K131663

510(k) Number K131663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2013
Decision Date October 18, 2013
Days to Decision 133 days
Submission Type Traditional
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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 276
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K131663.
ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS
K130738 · Nanjing Maidixin Medical Device Co., Ltd. · Dec 2013
OPTIFIX ABSORBABLE FIXATION SYSTEM
K132134 · C.R. Bard, Inc. · Dec 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K132493 · Covidien, LLC · Oct 2013
ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)
K131637 · Rotation Medical, Inc. · Jul 2013
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
K131511 · Changzhou Sinolinks Medical Innovation Co., Ltd. · Jul 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K131705 · Covidien, Formerly US Surgical A Divison of Tyco H · Jul 2013
K131663 · ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
Download PDF FDA Summary Ethicon Endo-Surgery,…