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 Needle, Assisted Reproduction
510(k) Number K232163
Device Name Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
Applicant
Zhejiang Horizon Medical Technology Co., Ltd.
Rm. 219, 2nd Floor, Bldg. 9, 1303 Asia-Pacific Rd.
Daqiao Town, Nanhu District
Jiaxing,  CN 314006
Applicant Contact Wu Tang
Correspondent
Zhejiang Horizon Medical Technology Co., Ltd.
Rm. 219, 2nd Floor, Bldg. 9, 1303 Asia-Pacific Rd.
Daqiao Town, Nanhu District
Jiaxing,  CN 314006
Correspondent Contact Wu Tang
Regulation Number884.6100
Classification Product Code
MQE  
Date Received07/21/2023
Decision Date 02/22/2024
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
-
-