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 Magnetic Compression Anastomosis System
510(k) Number K243213
Device Name Self-Forming Magnet (FLEX SFM)
Applicant
Gi Windows, Inc.
380 University Ave.
Westwood,  MA  02090
Applicant Contact Yverre Bobay
Correspondent
Gi Windows, Inc.
380 University Ave.
Westwood,  MA  02090
Correspondent Contact Yverre Bobay
Classification Product Code
SAH  
Date Received10/03/2024
Decision Date 01/29/2025
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
-
-