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 Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
510(k) Number K253923
Device Name PuraStat
Applicant
3-D Matrix Europe SAS
11 Chemin Des Petites Brosses
2nd Floor
Caluire Et Cuire,  FR 69300
Applicant Contact Audrey Vion
Correspondent
3-D Matrix Europe SAS
11 Chemin Des Petites Brosses
2nd Floor
Caluire Et Cuire,  FR 69300
Correspondent Contact Audrey Vion
Classification Product Code
PHN  
Date Received12/08/2025
Decision Date 01/07/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-