• 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 K191290
Device Name Ancora Nerve Block Catheter Set
Ancora Medical Technology
333 Ravenswood Ave
Menlo Park,  CA  94025
Applicant Contact Chunyuan Qiu
Decus Biomedical Inc
2342 Shattuck Ave #333
Berkeley,  CA  94704
Correspondent Contact Terri Bogucki
Regulation Number868.5150
Classification Product Code
Date Received05/13/2019
Decision Date 02/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No