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 K254196
Device Name HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)
Applicant
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00096
Applicant Contact Hillary Lewis
Correspondent
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00096
Correspondent Contact Hillary Lewis
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Codes
HGI   LFL  
Date Received12/23/2025
Decision Date 09/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-