Cleared Traditional

Hemospray Endoscopic Hemostat

K200972 · Wilson-Cook Medical, Inc. · General & Plastic Surgery
Jun 2020
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K200972 is an FDA 510(k) clearance for the Hemospray Endoscopic Hemostat, a Hemostatic Device For Endoscopic Gastrointestinal Use (Class II — Special Controls, product code QAU), submitted by Wilson-Cook Medical, Inc. (Winstrom-Salem, US). The FDA issued a Cleared decision on June 10, 2020, 58 days after receiving the submission on April 13, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4456.

Submission Details

510(k) Number K200972 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2020
Decision Date June 10, 2020
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code QAU — Hemostatic Device For Endoscopic Gastrointestinal Use
Device Class Class II — 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.