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 laparoscope, general & plastic surgery
510(k) Number K101077
Device Name DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
Applicant
INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE,  CA  94086 -5206
Applicant Contact KAREN UYESUGI
Correspondent
INTUITIVE SURGICAL, INC.
950 KIFER RD.
SUNNYVALE,  CA  94086 -5206
Correspondent Contact KAREN UYESUGI
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Codes
IZI   NAY  
Date Received04/19/2010
Decision Date 02/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
-
-