Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
510(k) Number K253290
Device Name XSTAT P15
Applicant
Revmedx, Inc.
25749 S W Canyon Creek Rd.
Suite 300
Wilsonville,  OR  97070
Applicant Contact Amy K. Pointer
Correspondent
Revmedx, Inc.
25749 S W Canyon Creek Rd.
Suite 300
Wilsonville,  OR  97070
Correspondent Contact Amy K. Pointer
Regulation Number878.4452
Classification Product Code
PGZ  
Subsequent Product Code
NAB  
Date Received09/29/2025
Decision Date 11/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-