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 Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K240964
Device Name FLOW 90? Wand
Applicant
ArthroCare Corporation
7000 W. William Cannon Dr.
Austin,  TX  78735
Applicant Contact Srividya Pothana
Correspondent
ArthroCare Corporation
7000 W. William Cannon Dr.
Austin,  TX  78735
Correspondent Contact Srividya Pothana
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/09/2024
Decision Date 05/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-