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 needle, conduction, anesthetic (w/wo introducer)
510(k) Number K163216
Device Name Pinpoint GT Needles
Applicant
C.R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact Silvia De La Barra
Correspondent
C.R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact Silvia De La Barra
Regulation Number868.5150
Classification Product Code
BSP  
Date Received11/16/2016
Decision Date 06/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-