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 System, Surgical, Computer Controlled Instrument
510(k) Number K254192
Device Name Senhance Ultrasonic System
Applicant
Asensus Surgical
1 Tw Alexander Dr., Suite 160
Durham,  NC  27701
Applicant Contact Madhuvanthi Soundirarajan
Correspondent
Asensus Surgical
1 Tw Alexander Dr., Suite 160
Durham,  NC  27701
Correspondent Contact Madhuvanthi Soundirarajan
Regulation Number876.1500
Classification Product Code
NAY  
Date Received12/23/2025
Decision Date 05/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-