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 Catheter, Urethral
510(k) Number K241734
Device Name Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
Applicant
Well Lead Medical Co., Ltd.
# 47, Guomao Ave. S., Hualong, Panyu
Guangzhou,  CN 511434
Applicant Contact Jenny Zhu
Correspondent
Well Lead Medical Co., Ltd.
# 47, Guomao Ave. S., Hualong, Panyu
Guangzhou,  CN 511434
Correspondent Contact Jimmy Chen
Regulation Number876.5130
Classification Product Code
GBM  
Date Received06/17/2024
Decision Date 03/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-