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 accessories, catheter, g-u
510(k) Number K051593
Device Name UROPASS URETERAL ACCESS SHEATH, MODEL 61224
Applicant
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Applicant Contact GRAHAM BAILLIE
Correspondent
ACMI CORPORATION
136 TURNPIKE RD.
SOUTHBOROUGH,  MA  01772
Correspondent Contact GRAHAM BAILLIE
Regulation Number876.5130
Classification Product Code
KNY  
Date Received06/16/2005
Decision Date 09/02/2005
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
Recalls CDRH Recalls
-
-