Urological Catheter
FDA 510(k) K881646 · Coeur Laboratories, Inc.
510(k) numberK881646
Submission
- Device name
- Urological Catheter
- Applicant
- Coeur Laboratories, Inc.
Raleigh, NC, US - Received
- April 15, 1988
- Decision date
- June 16, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K971712 | Coeur 130 ML Angiographic SyringeDXT · Traditional | 10/08/1997SE |
| K965214 | Coeur Front Load Injector Retrofit Kit (C859-0002)DTX · Traditional | 03/28/1997SE |
| K960965 | Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211DXT · Traditional | 09/12/1996SE |
| K890292 | PCA-10, 10CC Disp. Angiography Control SyringeDXT · Traditional | 06/22/1989SE |
| K885138 | Capillary Tube, Blood CollectionGIO · Traditional | 02/07/1989SE |
| K885202 | 16 Long Catheter W/Adapter, 14 FR and 12 FRKOD · Traditional | 01/31/1989SE |
| K874579 | Coeur Control SyringeFMF · Traditional | 01/19/1988SE |
| K873597 | Tubing, PolyethyleneDXT · Traditional | 11/12/1987SE |
| K823920 | Coeurlock Sterile Dispos. AngiographicDXT · Traditional | 02/18/1983SE |
Questions and answers
When was Urological Catheter cleared by the FDA?
Urological Catheter (K881646) received a 510(k) decision of Substantially Equivalent on June 16, 1988, 62 days after the submission was received.
What is the product code of K881646?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.