Cleared Traditional

K172132 - CleanCision Wound Retraction and Protection System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172132 · Prescient Surgical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
103d
Days
Class 2
Risk

K172132 is an FDA 510(k) clearance for the CleanCision Wound Retraction and Protection System. Classified as Wound Retraction And Protection System (product code PQI), Class II - Special Controls.

Submitted by Prescient Surgical, Inc. (San Carlos, US). The FDA issued a Cleared decision on October 25, 2017 after a review of 103 days - within the typical 510(k) review window.

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 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 Prescient Surgical, Inc. devices

Submission Details

510(k) Number K172132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2017
Decision Date October 25, 2017
Days to Decision 103 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
11d faster than avg
Panel avg: 114d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.