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 Temporary Tissue Marker
510(k) Number K200734
Device Name Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
Applicant
Sirius Medical Systems B.V.
High Tech Campus 41
Eindhoven,  NL 5656AE
Applicant Contact Bram Schermers
Correspondent
Sirius Medical Systems B.V.
High Tech Campus 41
Eindhoven,  NL 5656AE
Correspondent Contact Bram Schermers
Regulation Number878.4300
Classification Product Code
PBY  
Date Received03/20/2020
Decision Date 02/24/2021
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
-
-