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 Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K243176
Device Name BLESSING System
Applicant
Cellah Medical Co., Ltd.
1513, 75-24, Gasan Digital 1-Ro, Geumcheon-Gu
(Gasandong, Gasna Is Bis Tower)
Seoul,  KR 08589
Applicant Contact Priscilla Chung
Correspondent
Cellah Medical Co., Ltd.
1513, 75-24, Gasan Digital 1-Ro, Geumcheon-Gu
(Gasandong, Gasna Is Bis Tower)
Seoul,  KR 08589
Correspondent Contact Priscilla Chung
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
OUH  
Date Received09/30/2024
Decision Date 05/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-