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 Lavage, Jet
510(k) Number K253996
Device Name BD Surgiphor™ Antimicrobial Irrigation System (910110)
Applicant
Becton, Dickinson and Company (BD)
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact Daniel Ehrhardt
Correspondent
Becton, Dickinson and Company (BD)
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact Daniel Ehrhardt
Regulation Number880.5475
Classification Product Code
FQH  
Subsequent Product Code
FRO  
Date Received12/12/2025
Decision Date 02/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-