KOD — Catheter, Urological Class II
FDA product code KOD covers "Catheter, Urological", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KOD
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251864 | C.R. Bard | Rubber Utility Catheter | Feb 23, 2026 |
| K220036 | Well Lead Medical Co | Wellead Ureteral Catheter | Dec 16, 2022 |
| K220730 | Allwin Medical Devices | allFlex Ureteral Catheters, Krait Ureteral Catheters | Oct 13, 2022 |
| K211032 | Urogen Pharma | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Nov 19, 2021 |
| K181979 | Teleflexmedical | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | May 24, 2019 |
| K180354 | Urogen Pharma | UroGen Ureteral Catheter | Oct 30, 2018 |
| K181144 | Cook Incorporated | Angled Tip Ureteral Catheter | Jun 28, 2018 |
| K180530 | Boston Scientific Corporation | Imager II Urology Torque Catheter | Apr 10, 2018 |
| K171810 | Cook Incorporated | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Mar 7, 2018 |
| K171600 | Cook Incorporated | Renal Access Cobra Catheter, Kumpe Access Catheter | Feb 16, 2018 |
| K171662 | Cook Incorporated | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-En | Feb 1, 2018 |
| K172924 | Convatec Limited | GentleCath Intermittent Urinary Catheter | Nov 21, 2017 |
| K161344 | Convatec Limited | GentleCath Glide Intermittent Catheter | Sep 20, 2016 |
| K160877 | Robling Medical | United Urologics Closed System Catheter | May 20, 2016 |
| K140953 | Convatec | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER | Aug 1, 2014 |
| K110491 | Pluromed | BACKSTOP CATHETER | Mar 16, 2011 |
| K103349 | Pluromed | BACKSTOP CATHETER | Jan 7, 2011 |
| K102527 | Boston Scientific Corporation | IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C | Nov 5, 2010 |
| K090270 | Pluromed | BACKSTOP CATHETER, MODEL 60-0000-3100 | May 15, 2009 |
| K080878 | Medical Technologies Of Georgia | MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WIT | Jul 17, 2008 |