Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic)
FDA 510(k) K000723 · Rochester Medical Corp.
510(k) numberK000723
Submission
- Device name
- Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic)
- Applicant
- Rochester Medical Corp.
Stewartville, MN, US - Received
- March 6, 2000
- Decision date
- May 19, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOD – Catheter, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251864 | Rubber Utility CatheterKOD · Traditional | C.R. Bard, Inc. | 02/23/2026SE |
| K220036 | Wellead Ureteral CatheterKOD · Traditional | Well Lead Medical Co., Ltd. | 12/16/2022SE |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral CathetersKOD · Traditional | Allwin Medical Devices, Inc. | 10/13/2022SE |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 FrKOD · Traditional | Urogen Pharma, Ltd. | 11/19/2021SE |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterKOD · Traditional | Teleflexmedical, Inc. | 05/24/2019SE |
| K180354 | UroGen Ureteral CatheterKOD · Traditional | Urogen Pharma, Ltd. | 10/30/2018SE |
| K181144 | Angled Tip Ureteral CatheterKOD · Traditional | Cook Incorporated | 06/28/2018SE |
| K180530 | Imager II Urology Torque CatheterKOD · Special | Boston Scientific Corporation | 04/10/2018SE |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterKOD · Traditional | Cook Incorporated | 03/07/2018SE |
| K171600 | Renal Access Cobra Catheter, Kumpe Access CatheterKOD · Traditional | Cook Incorporated | 02/16/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K122785 | Hydrosil; Magic; Personal CatheterEZD · Traditional | 05/14/2013SE |
| K033477 | Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitMJC · Traditional | 06/10/2004SE |
| K001143 | Release NF Antibacterial Foley Catheter, Antibacterial Personal CatheterMJC · Traditional | 07/07/2000SE |
| K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way…EZL · Traditional | 07/08/1998SE |
| K971627 | Silicone Antibacterial Foley CatheterMJC · Traditional | 01/13/1998SE |
| K970704 | Personal CatheterGBM · Traditional | 03/13/1997SE |
| K952082 | Rochester Medical Corporation Silicone Male External CatheterEXJ · Traditional | 07/18/1995SE |
| K941692 | Female Length All Silicone Urological CatheterEZL · Traditional | 03/06/1995SE |
| K943851 | All Silicone Intermittent CatheterGBM · Traditional | 01/31/1995SE |
| K923136 | Male External CatheterEXJ · Traditional | 12/03/1992SE |
Questions and answers
When was Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic) cleared by the FDA?
Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic) (K000723) received a 510(k) decision of Substantially Equivalent on May 19, 2000, 74 days after the submission was received.
What is the product code of K000723?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.