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 endoscopic injection needle, gastroenterology-urology
510(k) Number K221054
Device Name CORE-INJECTOR
Applicant
Incore Co., Ltd.
11, Hyeoksin-daero, 78-gil, Dong-gu
Daegu,  KR 41072
Applicant Contact Jae-Hun Lee
Correspondent
Incore Co., Ltd.
11, Hyeoksin-daero, 78-gil, Dong-gu
Daegu,  KR 41072
Correspondent Contact Jae-Hun Lee
Regulation Number876.1500
Classification Product Code
FBK  
Date Received04/11/2022
Decision Date 12/21/2022
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
-
-