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, Straight
510(k) Number K252943
Device Name GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
Applicant
Convatec Limited
First Ave.
Deeside Industrial Park
Deeside, Flintshire,  GB CH5 2NU
Applicant Contact Danielle Gibboney
Correspondent
Convatec Limited
First Ave.
Deeside Industrial Park
Deeside, Flintshire,  GB CH5 2NU
Correspondent Contact Danielle Gibboney
Regulation Number876.5130
Classification Product Code
EZD  
Date Received09/15/2025
Decision Date 04/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-