Not Cleared Direct

DEN150038 - CleanCisionTM Wound Retraction and Protection System (FDA 510(k) Clearance)

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

DEN150038 · Prescient Surgical · General & Plastic Surgery device
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Dec 2016
Decision
491d
Days
Class 2
Risk

DEN150038 is an FDA 510(k) submission (not cleared) for the CleanCisionTM Wound Retraction and Protection System. Classified as Wound Retraction And Protection System (product code PQI), Class II - Special Controls.

Submitted by Prescient Surgical (San Carlos, US). The FDA issued a Not Cleared (DENG) decision on December 16, 2016 after a review of 491 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4371 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 491 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Prescient Surgical devices

Submission Details

510(k) Number DEN150038 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 13, 2015
Decision Date December 16, 2016
Days to Decision 491 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
377d slower than avg
Panel avg: 114d · This submission: 491d
Pathway characteristics

Device Classification

Product Code PQI Wound Retraction And Protection System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4371
Definition A Prescription Device Intended To Be Used By A Surgeon To Retract The Surgical Incision, To Provide Access To The Surgical Wound, To Protect And Irrigate The Surgical Wound, And To Serve As A Conduit For Removal Of Fluid From The Surgical Wound.
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.