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 Biopsy Needle
510(k) Number K083330
Device Name ECHOTIP ULTRA ULTRASOUND NEEDLE
Applicant
COOK ENDOSCOPY
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM,  NC  27105
Applicant Contact SCOTTIE FARIOLE
Correspondent
COOK ENDOSCOPY
4900 BETHANIA STATION RD. &
5951 GRASSY CREEK BLVD.
WINSTON-SALEM,  NC  27105
Correspondent Contact SCOTTIE FARIOLE
Regulation Number876.1075
Classification Product Code
FCG  
Date Received11/12/2008
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-