• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K120468
Models SSEB-1.5-115-10, SSEB-1.7-115-8
Device Name NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR
Original Applicant
COOK INCORPORATED
750 daniels way
bloomington,  IN  47404
Original Contact susanne galin
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/16/2012
Decision Date 07/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-