Footprint Urinary Drainage Catheter
FDA 510(k) K090576 · Footprint Medical
510(k) numberK090576
Submission
- Device name
- Footprint Urinary Drainage Catheter
- Applicant
- Footprint Medical
San Antonio, TX, US - Received
- March 3, 2009
- Decision date
- August 12, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K253295 | Coude Sleeved IC; Coude Plus Sleeved ICEZD · Traditional | Hollister Incorporated | 05/18/2026SE |
| 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 |
More from Jamjoom Fullcare Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K130507 | Footprint Medical Polyurethane Picc CatheterLJS · Special | 06/03/2013SE |
| K120304 | Footprint Medical Polyurethane Umbilical CatheterFOS · Special | 03/01/2012SE |
| K102548 | Footprint Medical Polyurethane Feeding TubeKNT · Traditional | 11/26/2010SE |
| K093026 | Footprint Medical 1.9 FR Picc IntroducerDYB · Traditional | 02/24/2010SE |
| K093252 | Footprint Medical Peripherally Inserted Central CatheterLJS · Special | 12/17/2009SE |
| K091214 | Footprint Medical Silicone Umbilical CatheterFOS · Traditional | 09/25/2009SE |
| K091213 | Footprint Medical Umbilical Catheter, Dual LumenFOS · Traditional | 09/25/2009SE |
| K091488 | Footprint Medical Peripherally Inserted Central Catheter, Model S1PIC1.9-CLJS · Traditional | 09/14/2009SE |
| K090559 | Footprint Medical Silicone Feeding TubeKNT · Traditional | 05/04/2009SE |
Questions and answers
When was Footprint Urinary Drainage Catheter cleared by the FDA?
Footprint Urinary Drainage Catheter (K090576) received a 510(k) decision of Substantially Equivalent on August 12, 2009, 162 days after the submission was received.
What is the product code of K090576?
The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.