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 Arthroscope
510(k) Number K151932
Device Name Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing
Applicant
Stryker Corporation
5900 Optical Ct.
San Jose,  CA  95138
Applicant Contact SOMI EKWEALOR
Correspondent
Stryker Corporation
5900 Optical Ct.
San Jose,  CA  95138
Correspondent Contact SOMI EKWEALOR
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/14/2015
Decision Date 03/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-