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 Hysteroscope (And Accessories)
510(k) Number K252793
Device Name ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)
Applicant
Jiangsu Jiyuan Medical Technology Co., Ltd.
# 48 Cecep (Taizhou) Environmental Protection Technology
Industry Park, #59 Meilan Rd.
Taizhou,  CN
Applicant Contact Yunfeng Zong
Correspondent
Jiangsu Jiyuan Medical Technology Co., Ltd.
# 48 Cecep (Taizhou) Environmental Protection Technology
Industry Park, #59 Meilan Rd.
Taizhou,  CN
Correspondent Contact Yan Yao
Regulation Number884.1690
Classification Product Code
HIH  
Date Received08/29/2025
Decision Date 12/18/2025
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
-
-