GBM · Catheter, Urethral
Gastroenterology, Urology · 21 CFR 876.5130 · Class 2
Overview
| Product Code | GBM |
|---|---|
| Device Name | Catheter, Urethral |
| 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 71)
Showing 20 most recent of 71 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact | Well Lead Medical Co., Ltd. | Mar 5, 2025 | SESE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | Convatec Limited | Jun 22, 2022 | SESE |
| K211436 | Intermittent Catheter (Not Finalized) | Hollister Incorporated | Jan 27, 2022 | SESE |
| K200820 | SpeediCath Compact Set | Coloplast | Nov 13, 2020 | SESE |
| K192904 | SpeediCath Compact Set | Coloplast | Nov 2, 2020 | SESE |
| K200142 | SpeediCath Soft | Coloplast | Jul 30, 2020 | SESE |
| K200134 | Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | Jun 1, 2020 | SESE |
| K191512 | LotusCatheter (Lotus No Balloon Catheter) | Hakki Medical Technologies, Inc. | May 21, 2020 | SESK |
| K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | B.Braun Medical, Inc. | May 7, 2020 | SESE |
| K193148 | VaPro Plus Pocket, VaPro Plus | Hollister Incorporated | Dec 13, 2019 | SESE |
| K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter | Hangzhou Bever Medical Devices Co., Ltd. | Nov 27, 2019 | SESE |
| K191633 | Infyna Chic | Hollister Incorporated | Jul 19, 2019 | SESE |
| K190620 | SpeediCath Flex Coude Pro | Coloplast | Jul 10, 2019 | SESE |
| K183335 | Medline Poly-Cath Red Polymer Urethral Catheter | Medline Industries, Inc. | Jun 12, 2019 | SESE |
| K183461 | Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | May 8, 2019 | SESK |
| K182511 | SimplCath | F&S Medical Solutions, LLC | Mar 20, 2019 | SESE |
| K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | Hollister Incorporated | Dec 18, 2018 | SESE |
| K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | B.Braun Medical, Inc. | Nov 5, 2018 | SESE |
| K180258 | SpeediCath Standard | Coloplast | Oct 25, 2018 | SESE |
| K181206 | GentleCath Glide Intermittent Urinary Catheter | Convatec Limited | Aug 16, 2018 | SESE |
Top Applicants
- Hollister Incorporated — 10 clearances
- Coloplast — 6 clearances
- Coloplast Corp. — 4 clearances
- Astra Tech, Inc. — 3 clearances
- B.Braun Medical, Inc. — 3 clearances
