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510(k) K202929

Device
Nexpowder
Applicant
Nextbiomedical Co., Ltd.
510(k) number
K202929
Product code
QAU  
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-16
Date received
2020-09-29
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
Jin Young Lee
Address
6, Venture-Ro 100beon-Gil, Yeonsu-Gu Incheon KR 22013 22013

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
K210098PuraStat-GI3-D Matrix, Inc.2021-06-25
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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