Urinary Catheters
FDA 510(k) K031409 · Promedic, Inc.
510(k) numberK031409
Submission
- Device name
- Urinary Catheters
- Applicant
- Promedic, Inc.
Mccordsville, IN, US - Received
- May 5, 2003
- Decision date
- June 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GBM – Catheter, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GBM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional | Well Lead Medical Co., Ltd. | 03/05/2025SE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | Convatec Limited | 06/22/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | Hollister Incorporated | 01/27/2022SE |
| K200820 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/13/2020SE |
| K192904 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/02/2020SE |
| K200142 | SpeediCath SoftGBM · Traditional | Coloplast | 07/30/2020SE |
| K200134 | Jimushi Sterile Urethral Catheter for single useGBM · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/01/2020SE |
| K191512 | LotusCatheter (Lotus No Balloon Catheter)GBM · Traditional | Hakki Medical Technologies, Inc. | 05/21/2020SESK |
| K192577 | Actreen Hi-Lite Intermittent Urinary CathetersGBM · Special | B.Braun Medical, Inc. | 05/07/2020SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | Hollister Incorporated | 12/13/2019SE |
More from Hollister Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K131889 | Eum 100PROOSP · Traditional | 04/23/2014SE |
| K112318 | Clearpath 24OCX · Traditional | 06/29/2012SE |
| K072756 | Non-Iv Adapter for Infant NG TubeKNT · Traditional | 12/19/2007SESK |
| K060497 | BabyairCAF · Traditional | 07/11/2006SE |
| K060842 | Revjet TurboCAF · Traditional | 06/21/2006SE |
| K052903 | Pediatric Feeding TubeKNT · Traditional | 11/09/2005SE |
| K024190 | Fenestrated Infusion CatheterFRN · Traditional | 03/17/2003SE |
| K023579 | Gas Sampling LinesCCK · Traditional | 01/28/2003SE |
| K020005 | Infant Feeding TubesKNT · Traditional | 07/16/2002SE |
| K970102 | FilterCAH · Traditional | 06/24/1997SE |
Questions and answers
When was Urinary Catheters cleared by the FDA?
Urinary Catheters (K031409) received a 510(k) decision of Substantially Equivalent on June 17, 2003, 43 days after the submission was received.
What is the product code of K031409?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.