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 K252388
Device Name Vanquish Water Vapor Ablation Device
Applicant
Francis Medical, Inc.
7351 Kirkwood Ln N, Suite 130
Maple Grove,  MN  55369
Applicant Contact Mike Kujak
Correspondent
RQM+
2790 Mosside Blvd. #800
Monroeville,  PA  15146
Correspondent Contact Alexia Haralambous
Regulation Number876.4300
Classification Product Code
KNS  
Date Received07/31/2025
Decision Date 11/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT05683691
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-