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 K210978
Device Name BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle
Applicant
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact Nikita Abirami Mahendra Kumar
Correspondent
Becton, Dickinson and Company
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact Nikita Abirami Mahendra Kumar
Regulation Number868.5150
Classification Product Code
BSP  
Date Received04/01/2021
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-