Cleared Special

K130653 - ECHELON FLEX 45 POWERED ARTICULATING EN...

Also marketed or referenced as:
ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU

K130653 is the FDA 510(k) clearance for ECHELON FLEX 45 POWERED ARTICULATING EN... by Ethicon Endo-Surgery, LLC. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Special 510(k) pathway after a 17-day FDA review.

K130653 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
17d
Days
Class 2
Risk

K130653 is an FDA 510(k) clearance for the ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER. 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 March 29, 2013 after a review of 17 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 Ethicon Endo-Surgery, LLC devices

Submission Details

510(k) Number K130653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date March 29, 2013
Days to Decision 17 days
Submission Type Special
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
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 152
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