510(k) DEN170015

Hemospray Endoscopic Hemostat by Wilson-Cook Medical, Inc. — Product Code QAU

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: May 7, 2018
Date Received: March 9, 2017
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Hemostatic Device For Endoscopic Gastrointestinal Use
Device Class: Class II
Regulation Number: 878.4456
Review Panel: SU
Submission Type

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.

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K193344 — Tri-Ex Extraction Balloon with Multiple Sizing (December 13, 2019)
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Other clearances for product code QAU

K253924 — PuraStat (January 7, 2026)
K240994 — Nexpowder (November 27, 2024)
K242250 — PuraStat (October 22, 2024)
K234131 — Resolv Endoscopic Hemostat System (July 26, 2024)
K222481 — PuraStat (February 28, 2023)
K202929 — Nexpowder (September 16, 2022)
K210098 — PuraStat-GI (June 25, 2021)
K190677 — EndoClot (January 29, 2021)
K200972 — Hemospray Endoscopic Hemostat (June 10, 2020)