KOD — Catheter, Urological Class II
FDA Device Classification
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 | February 23, 2026 |
| K220036 | well lead medical co | Wellead Ureteral Catheter | December 16, 2022 |
| K220730 | allwin medical devices | allFlex Ureteral Catheters, Krait Ureteral Catheters | October 13, 2022 |
| K211032 | urogen pharma | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | November 19, 2021 |
| K181979 | teleflexmedical | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | May 24, 2019 |
| K180354 | urogen pharma | UroGen Ureteral Catheter | October 30, 2018 |
| K181144 | cook incorporated | Angled Tip Ureteral Catheter | June 28, 2018 |
| K180530 | boston scientific corporation | Imager II Urology Torque Catheter | April 10, 2018 |
| K171810 | cook incorporated | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | March 7, 2018 |
| K171600 | cook incorporated | Renal Access Cobra Catheter, Kumpe Access Catheter | February 16, 2018 |
| K171662 | cook incorporated | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-En | February 1, 2018 |
| K172924 | convatec limited | GentleCath Intermittent Urinary Catheter | November 21, 2017 |
| K161344 | convatec limited | GentleCath Glide Intermittent Catheter | September 20, 2016 |
| K160877 | robling medical | United Urologics Closed System Catheter | May 20, 2016 |
| K140953 | convatec | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER | August 1, 2014 |
| K110491 | pluromed | BACKSTOP CATHETER | March 16, 2011 |
| K103349 | pluromed | BACKSTOP CATHETER | January 7, 2011 |
| K102527 | boston scientific corporation | IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C | November 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 | July 17, 2008 |