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 Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K231939
Device Name Renasys Edge
Applicant
Smith & Nephew Medical, Ltd.
101 Hessle Rd.
Hull,  GB HU32BN
Applicant Contact Uttley Ruby
Correspondent
Smith & Nephew Medical, Ltd.
101 Hessle Rd.
Hull,  GB HU32BN
Correspondent Contact Uttley Ruby
Regulation Number878.4780
Classification Product Code
OMP  
Date Received06/30/2023
Decision Date 05/24/2024
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
-
-