O'Neil Urinary Catheter Introducer
FDA 510(k) K854443 · Pennine Medical , Ltd.
510(k) numberK854443
Submission
- Device name
- O'Neil Urinary Catheter Introducer
- Applicant
- Pennine Medical , Ltd.
Stoughton, MA, US - Received
- November 5, 1985
- Decision date
- January 8, 1986
- 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 |
|---|---|---|
| K852859 | Pennine Connecting Tubing · Traditional | 07/30/1985SE |
| K852081 | Pennine Oxygen Link TubingBYX · Traditional | 06/14/1985SE |
| K844874 | Pennine Link YankauersGEA · Traditional | 06/06/1985SE |
| K844876 | Pennine Nelaton Catheters Sizes 5,6,8,10,12,14,16,GBX · Traditional | 06/05/1985SE |
| K852080 | Pennine Suction CathetersBSY · Traditional | 06/03/1985SE |
| K852079 | Pennine Derby YankauerBSY · Traditional | 06/03/1985SE |
| K844873 | Pennine Guedel Airway 00,0,1,2,3 & 4CAE · Traditional | 02/21/1985SE |
Questions and answers
When was O'Neil Urinary Catheter Introducer cleared by the FDA?
O'Neil Urinary Catheter Introducer (K854443) received a 510(k) decision of Substantially Equivalent on January 8, 1986, 64 days after the submission was received.
What is the product code of K854443?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.