Coude Sleeved IC; Coude Plus Sleeved IC
FDA 510(k) K253295 · Hollister Incorporated
510(k) numberK253295
Submission
- Device name
- Coude Sleeved IC; Coude Plus Sleeved IC
- Applicant
- Hollister Incorporated
Libertyville, IL, US - Received
- September 29, 2025
- Decision date
- May 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZD – Catheter, Straight
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…EZD · Traditional | Convatec | 08/05/2026SE |
| K261658 | LoFric Origo Pro CoudéEZD · Special | Wellspect AB | 07/17/2026SE |
| K262045 | Luja SoftEZD · Special | Coloplast A.S. | 07/07/2026SE |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)EZD · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/24/2026SE |
| K260999 | LoFric Elle ProEZD · Special | Wellspect AB | 04/24/2026SE |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD · Traditional | Convatec Limited | 04/01/2026SE |
| K260502 | Liv Pre-lubricated Intermittent CatheterEZD · Traditional | HR Healthcare | 03/12/2026SE |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic…EZD · Traditional | HR Healthcare | 01/29/2026SESK |
| K251178 | Ready to use Nelaton CatheterEZD · Traditional | Jamjoom Fullcare Corporation | 01/02/2026SE |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…EZD · Traditional | Hollister Incorporated | 10/03/2025SE |
More from Hollister Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…EZD · Traditional | 10/03/2025SE |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…EZD · Traditional | 05/03/2024SE |
| K220667 | Sleeved ICEZD · Traditional | 12/08/2022SE |
| K213575 | Female IC (Not Finalized)EZD · Traditional | 09/13/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | 01/27/2022SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | 12/13/2019SE |
| K191633 | Infyna ChicGBM · Special | 07/19/2019SE |
| K183253 | ValPro 2 Plus, VaPro 2 Plus PocketGBM · Special | 12/18/2018SE |
| K180824 | VaPro 2 Intermittent CatheterGBM · Special | 06/22/2018SE |
| K163179 | Onli Intermittent CatheterGBM · Special | 01/26/2017SE |
Questions and answers
When was Coude Sleeved IC; Coude Plus Sleeved IC cleared by the FDA?
Coude Sleeved IC; Coude Plus Sleeved IC (K253295) received a 510(k) decision of Substantially Equivalent on May 18, 2026, 231 days after the submission was received.
What is the product code of K253295?
The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.