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 | 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 |