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 K251637
Device Name Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
Applicant
Donnevie Medical Technology (Shanghai) Co. , Ltd.
Suite 201, Bld. 1, 138 Xinjun Ring
Minhang District
Shanghai,  CN 201114
Applicant Contact Hannah Hang Yin
Correspondent
Donnevie Medical Technology (Shanghai) Co. , Ltd.
Suite 201, Bld. 1, 138 Xinjun Ring
Minhang District
Shanghai,  CN 201114
Correspondent Contact Lily Liu
Regulation Number884.6180
Classification Product Code
MQL  
Date Received05/29/2025
Decision Date 08/27/2025
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
-
-