Not Cleared Post-NSE

DEN110016 - PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN110016 · Ethicon Endo-Surgery · General & Plastic Surgery device
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Apr 2012
Decision
222d
Days
Class 2
Risk

DEN110016 is an FDA 510(k) submission (not cleared) for the PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS. Classified as Percutaneous Surgical Set With Attachments (product code OXT), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery (Cincinnati, US). The FDA issued a Not Cleared (DENG) decision on April 30, 2012 after a review of 222 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4805 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General & Plastic Surgery review framework.

View all Ethicon Endo-Surgery devices

Submission Details

510(k) Number DEN110016 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 21, 2011
Decision Date April 30, 2012
Days to Decision 222 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 114d · This submission: 222d
Pathway characteristics

Device Classification

Product Code OXT Percutaneous Surgical Set With Attachments
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4805
Definition Minimally Invasive Devices With The Means To Penetrate Soft Tissue To Access The Abdomen. The Attachment And The Shaft Will Be Assembled And Disassembled Within The Abdomen Before And After Use. The Devices Are Used To Grasp, Hold, And Manipulate Soft Tissues.
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.