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510(k) K210098

PuraStat-GI by 3-D Matrix, Inc. — Product Code QAU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2021
Date Received
January 14, 2021
Clearance Type
Traditional
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, Inc.

  • K222481 — PuraStat (February 28, 2023)
  • K213552 — PuraStat-RM (April 1, 2022)
  • K210211 — PuraStat-OM (October 8, 2021)
  • K193085 — PuraDERM Gel (May 11, 2020)
  • K183015 — PuraSinus (April 12, 2019)
  • K143058 — PuraDerm Gel (February 13, 2015)

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)
  • K190677 — EndoClot (January 29, 2021)
  • K200972 — Hemospray Endoscopic Hemostat (June 10, 2020)
  • DEN170015 — Hemospray Endoscopic Hemostat (May 7, 2018)