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 Washer, Cleaner, Automated, Endoscope
510(k) Number K073112
Device Name DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253
Applicant
Intuitive Surgical, Inc.
950 Kifer Rd.
Sunnyvale,  CA  94086
Applicant Contact MICHAEL H YRAMATEGUI
Correspondent
Intuitive Surgical, Inc.
950 Kifer Rd.
Sunnyvale,  CA  94086
Correspondent Contact MICHAEL H YRAMATEGUI
Regulation Number876.1500
Classification Product Code
NVE  
Date Received11/05/2007
Decision Date 08/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-