XSTAT 30 Pouch

Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

RevMedx, Inc.

The following data is part of a premarket notification filed by Revmedx, Inc. with the FDA for Xstat 30 Pouch.

Pre-market Notification Details

Device IDK210676
510k NumberK210676
Device Name:XSTAT 30 Pouch
ClassificationNon-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Applicant RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville,  OR  97070
ContactAmy K Pointer
CorrespondentAmy K Pointer
RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville,  OR  97070
Product CodePGZ  
CFR Regulation Number878.4452 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-05
Decision Date2021-08-27

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