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510(k) K210098

Device
PuraStat-GI
Applicant
3-D Matrix, Inc.
510(k) number
K210098
Product code
QAU  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-25
Date received
2021-01-14
Regulation
878.4456
Classification name
Hemostatic Device For Endoscopic Gastrointestinal Use
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Lisa Spirio
Address
1234 Chestnut St., Suite 205 Newton MA US 02464 02464

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QAU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253924PuraStat3-D Matrix Europe SAS2026-01-07
K240994NexpowderNextbiomedical Co., Ltd.2024-11-27
K242250PuraStat3-D Matrix Europe SAS2024-10-22
K234131Resolv Endoscopic Hemostat SystemHemostasis, LLC2024-07-26
K222481PuraStat3-D Matrix, Inc.2023-02-28
K202929NexpowderNextbiomedical Co., Ltd.2022-09-16
K190677EndoClotEndoclot Plus Co., Ltd.2021-01-29
K200972Hemospray Endoscopic HemostatWilson-Cook Medical, Inc.2020-06-10
DEN170015Hemospray Endoscopic HemostatWilson-Cook Medical, Inc.2018-05-07

Legacy Summary#

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FDA Review#

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