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 System, Surgical, Computer Controlled Instrument
510(k) Number K012833
Device Name INTUITIVE SURGICAL BIPOLAR FORCEPS
Applicant
INTUITIVE SURGICAL, INC.
1340 WEST MIDDLEFIELD RD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact MICHAEL YRAMATEGUI
Correspondent
INTUITIVE SURGICAL, INC.
1340 WEST MIDDLEFIELD RD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MICHAEL YRAMATEGUI
Regulation Number876.1500
Classification Product Code
NAY  
Date Received08/23/2001
Decision Date 11/16/2001
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 No
Recalls CDRH Recalls
-
-