KOD · Catheter, Urological
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | KOD |
|---|---|
| Device Name | Catheter, Urological |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).
Classification Rationale
(1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (20 of 238)
Showing 20 most recent of 238 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251864 | Rubber Utility Catheter | C.R. Bard, Inc. | Feb 23, 2026 | SESE |
| K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | Dec 16, 2022 | SESE |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | Allwin Medical Devices, Inc. | Oct 13, 2022 | SESE |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | Nov 19, 2021 | SESE |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | May 24, 2019 | SESE |
| K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | Oct 30, 2018 | SESE |
| K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | Jun 28, 2018 | SESE |
| K180530 | Imager II Urology Torque Catheter | Boston Scientific Corporation | Apr 10, 2018 | SESE |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | Mar 7, 2018 | SESE |
| K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated | Feb 16, 2018 | SESE |
| K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter | Cook Incorporated | Feb 1, 2018 | SESE |
| K172924 | GentleCath Intermittent Urinary Catheter | Convatec Limited | Nov 21, 2017 | SESE |
| K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | Sep 20, 2016 | SESE |
| K160877 | United Urologics Closed System Catheter | Robling Medical, Inc. | May 20, 2016 | SESE |
| K140953 | GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER | Convatec, Ltd. | Aug 1, 2014 | SESE |
| K110491 | BACKSTOP CATHETER | Pluromed, Inc. | Mar 16, 2011 | SESE |
| K103349 | BACKSTOP CATHETER | Pluromed, Inc. | Jan 7, 2011 | SESE |
| K102527 | IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER | Boston Scientific Corporation | Nov 5, 2010 | SESE |
| K090270 | BACKSTOP CATHETER, MODEL 60-0000-3100 | Pluromed, Inc. | May 15, 2009 | SESE |
| K080878 | MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) | Medical Technologies of Georgia, Inc. | Jul 17, 2008 | SESE |
Top Applicants
- C.R. Bard, Inc. — 10 clearances
- Abco Dealers, Inc. — 9 clearances
- Van-Tec, Inc. — 8 clearances
- The Kendal Co. — 7 clearances
- American Pharmaseal Div. Ahsc — 6 clearances
