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 ureteroscope and accessories, flexible/rigid
510(k) Number K121112
Device Name STRYKER VIDEO URETEROSCOPE
Applicant
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Applicant Contact KEVIN POTGIETER, RAC
Correspondent
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Correspondent Contact KEVIN POTGIETER, RAC
Regulation Number876.1500
Classification Product Code
FGB  
Date Received04/12/2012
Decision Date 09/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-