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510(k) K253924

PuraStat by 3-D Matrix Europe SAS — Product Code QAU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2026
Date Received
December 8, 2025
Clearance Type
Special
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.

Other clearances by 3-D Matrix Europe SAS

  • K253923 — PuraStat (January 7, 2026)
  • K242634 — PuraStat (January 15, 2025)
  • K242250 — PuraStat (October 22, 2024)

Other clearances for product code QAU

  • 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)
  • DEN170015 — Hemospray Endoscopic Hemostat (May 7, 2018)