GentleCath Intermittent Urinary Catheter
510(k) K172924
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172924 | Date21 Nov 2017 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KOD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The GentleCath Intermittent Urinary Catheter is a urological catheter, classified as a device with a regulation number of 876.5130. It is designed for intermittent use, providing a means for urinary drainage. The device is intended to facilitate easy and convenient cathing.
The GentleCath Intermittent Urinary Catheter is supplied by Convatec Limited, with an FDA 510K authorization. The device is part of the medical specialty of Gastroenterology and Urology, and has a product code of KOD. It is a single-use device, and its storage and handling instructions are not specified in the provided data.
Other devices from Convatec, Ltd.
Questions
AI-generated answers, 21 Sep 2026
What is the GentleCath Intermittent Urinary Catheter used for?
The GentleCath Intermittent Urinary Catheter is used for intermittent urinary drainage, providing a means for easy and convenient cathing.
Is the GentleCath Intermittent Urinary Catheter a single-use device?
Yes, the GentleCath Intermittent Urinary Catheter is a single-use device, intended for one-time use.
What is the regulatory classification of the GentleCath Intermittent Urinary Catheter?
The GentleCath Intermittent Urinary Catheter is classified as a device with a regulation number of 876.5130, and has been authorized with an FDA 510K clearance.