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 K261202
Device Name ENTire IRE System
Applicant
Entire Medical , Ltd.
11 Ha'Hoshlim St.
Herzeliya,  IL 4672411
Applicant Contact Hila Wachsler-Avrahami
Correspondent
MCRA, LLC
803 7th St. NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Glenn Stiegman
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/13/2026
Decision Date 05/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-