Busse Hospital Disposables Urethral Catheter
FDA 510(k) K041464 · Busse Hospital Disposables
510(k) numberK041464
Submission
- Device name
- Busse Hospital Disposables Urethral Catheter
- Applicant
- Busse Hospital Disposables
Hauppauge, NY, US - Received
- June 2, 2004
- Decision date
- November 5, 2004
- 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 |
| 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 |
|---|---|---|
| K141285 | Busse Extension SetFPA · Traditional | 02/19/2015SE |
| K120002 | I-Style Bone Marrow Aspiration Needle with T-HandleKNW · Traditional | 06/26/2012SE |
| K110883 | J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition CannulaKNW · Traditional | 06/08/2011SE |
| K093920 | Busse Epidural Catheter KitBSO · Traditional | 08/06/2010SE |
| K093909 | Busse Surgical Drapes IVKKX · Traditional | 05/06/2010SE |
| K092212 | Busse Surgical Drapes IIIKKX · Special | 10/09/2009SE |
| K082297 | Busse Surgical DrapeKKX · Traditional | 12/09/2008SE |
| K073222 | Modification To:Specialty NeedlesBSP · Special | 04/09/2008SE |
| K070465 | Busse Epidural CatheterBSO · Traditional | 07/19/2007SE |
| K063018 | Glass Loss of Resistance SyringeCAZ · Traditional | 01/22/2007SE |
Questions and answers
When was Busse Hospital Disposables Urethral Catheter cleared by the FDA?
Busse Hospital Disposables Urethral Catheter (K041464) received a 510(k) decision of Substantially Equivalent on November 5, 2004, 156 days after the submission was received.
What is the product code of K041464?
The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.