• 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 laparoscope, gynecologic (and accessories)
510(k) Number K150525
Device Name SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVE
EL SEGUNDO,  CA  90245
Applicant Contact SUSIE S. CHEN
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E.GRAND AVE
EL SEGUNDO,  CA  90245
Correspondent Contact WINKIE S. WONG
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
FGB   GCJ  
Date Received03/02/2015
Decision Date 11/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-