Not Cleared Direct

DEN170015 - Hemospray Endoscopic Hemostat

DEN170015 is the FDA 510(k) submission for Hemospray Endoscopic Hemostat by Wilson-Cook Medical, Inc.. It is a Class 2 General & Plastic Surgery device (product code QAU) cleared through the Direct 510(k) pathway after a 424-day FDA review.

DEN170015 · Wilson-Cook Medical, Inc. · General & Plastic Surgery device
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May 2018
Decision
424d
Days
Class 2
Risk

DEN170015 is an FDA 510(k) submission (not cleared) for the Hemospray Endoscopic Hemostat. Classified as Hemostatic Device For Endoscopic Gastrointestinal Use (product code QAU), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Not Cleared (DENG) decision on May 7, 2018 after a review of 424 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4456 - 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 424 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 Wilson-Cook Medical, Inc. devices

Submission Details

510(k) Number DEN170015 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 09, 2017
Decision Date May 07, 2018
Days to Decision 424 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
309d slower than avg
Panel avg: 115d · This submission: 424d
Pathway characteristics

Device Classification

Product Code QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4456
Definition Hemostatic Device For Intraluminal Gastrointestinal Use. A Hemostatic Device For Intraluminal Gastrointestinal Use Is A Prescription Device That Is Endoscopically Applied To The Upper And/or Lower Gastrointestinal Tract And Is Intended To Produce Hemostasis Via Absorption Of Fluid Or By Other Physical Means.
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.