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 Media, Reproductive
510(k) Number K260248
Device Name Ultra-Fast Warm
Applicant
Kitazato Corporation
100-10 Yanagishima
Fuji,  JP 416-0932
Applicant Contact Kyoko Izumi
Correspondent
BIOMEDICAL SUPPLY S.L. DBA DIBIMED
3 Jorge Comín Bajo 1-2
Valencia,  ES 46015
Correspondent Contact Belén Fos Guarinos
Regulation Number884.6180
Classification Product Code
MQL  
Date Received01/27/2026
Decision Date 04/28/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-