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 K141250
Device Name FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
Applicant
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Ave.
Los Angeles,  CA  90245
Applicant Contact LEIGH SPOTTEN
Correspondent
Karl Storz Endoscopy America, Inc.
2151 E Grand Ave.
El Segundo,  CA  90245 -5017
Correspondent Contact Leigh Spotten
Regulation Number876.1500
Classification Product Code
FGB  
Date Received05/14/2014
Decision Date 06/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-