Catheter Insertion Kit
FDA 510(k) K833432 · Clinipad Corp.
510(k) numberK833432
Submission
- Device name
- Catheter Insertion Kit
- Applicant
- Clinipad Corp.
Mchenry, IL, US - Received
- October 5, 1983
- Decision date
- December 28, 1983
- 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 |
|---|---|---|
| K931560 | Cardiac Catheterization TrayDQO · Traditional | 07/11/1994SEKD |
| K931668 | Picc Insertion TrayFOZ · Traditional | 03/07/1994SEKD |
| K932071 | I.V. Start KitFOZ · Traditional | 02/17/1994SEKD |
| K932010 | V.A.D. Access KitLJT · Traditional | 02/03/1994SE |
| K932036 | Laceration TrayFRG · Traditional | 12/13/1993SESK |
| K932016 | Tracheostomy Care TrayJOH · Traditional | 11/03/1993SE |
| K862562 | Punch Biopsy KitKNW · Traditional | 10/07/1986SE |
| K862563 | Tracheostomy Cleansing SolutionEPE · Traditional | 07/15/1986SE |
| K833075 | Wet Dressing KitKDD · Traditional | 01/27/1984SE |
| K830476 | Or Prep KitFRG · Traditional | 03/31/1983SE |
Questions and answers
When was Catheter Insertion Kit cleared by the FDA?
Catheter Insertion Kit (K833432) received a 510(k) decision of Substantially Equivalent on December 28, 1983, 84 days after the submission was received.
What is the product code of K833432?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.