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 Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K260962
Device Name Sphincterotome
Applicant
Taewoong Medical Co., Ltd.
14 Gojeong-Ro
Wolgot-Myeon
Gimpo-Si,  KR 10022
Applicant Contact Yongjin "Jeff" Kim
Correspondent
Biologics Consulting Group, Inc.
100 Daingerfield Rd.
Suite 101
Alexandria,  VA  22314
Correspondent Contact Matthew Krueger
Regulation Number876.4300
Classification Product Code
KNS  
Date Received03/23/2026
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-