GentleCath Glide Intermittent Urinary Catheter
FDA 510(k) K181206 · Convatec Limited
510(k) numberK181206
Submission
- Device name
- GentleCath Glide Intermittent Urinary Catheter
- Applicant
- Convatec Limited
Deeside, GB - Received
- May 7, 2018
- Decision date
- August 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GBM – Catheter, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GBM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional | Well Lead Medical Co., Ltd. | 03/05/2025SE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | Convatec Limited | 06/22/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | Hollister Incorporated | 01/27/2022SE |
| K200820 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/13/2020SE |
| K192904 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/02/2020SE |
| K200142 | SpeediCath SoftGBM · Traditional | Coloplast | 07/30/2020SE |
| K200134 | Jimushi Sterile Urethral Catheter for single useGBM · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/01/2020SE |
| K191512 | LotusCatheter (Lotus No Balloon Catheter)GBM · Traditional | Hakki Medical Technologies, Inc. | 05/21/2020SESK |
| K192577 | Actreen Hi-Lite Intermittent Urinary CathetersGBM · Special | B.Braun Medical, Inc. | 05/07/2020SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | Hollister Incorporated | 12/13/2019SE |
More from Hollister Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…EZD · Traditional | 08/05/2026SE |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD · Traditional | 04/01/2026SE |
| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist…EZD · Traditional | 07/01/2025SE |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter…FCM · Special | 06/06/2025SESK |
| K243228 | Flexi-Seal AIR (with ENFit Connector)KNT · Traditional | 03/28/2025SE |
| K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for…EZD · Traditional | 01/25/2024SE |
| K230400 | Cure Catheter Closed System; Cure Dextra Closed SystemEZD · Traditional | 11/08/2023SESK |
| K221593 | Cure Ultra Male, Cure Ultra Female, Cure Ultra PlusEZD · Traditional | 11/17/2022SE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | 06/22/2022SE |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)KNT · Traditional | 04/30/2019SE |
Questions and answers
When was GentleCath Glide Intermittent Urinary Catheter cleared by the FDA?
GentleCath Glide Intermittent Urinary Catheter (K181206) received a 510(k) decision of Substantially Equivalent on August 16, 2018, 101 days after the submission was received.
What is the product code of K181206?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.