MMG Uro-Self Catheter
FDA 510(k) K871999 · Medical Marketing Group
510(k) numberK871999
Submission
- Device name
- MMG Uro-Self Catheter
- Applicant
- Medical Marketing Group
Decatur, GA, US - Received
- May 26, 1987
- Decision date
- August 25, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K910022 | Mmg/O'Neil Urinary Catheterization System KitFCM · Traditional | 04/02/1991SEKD |
| K884819 | O'Neil Urinary Catheter IntroducerKNY · Traditional | 02/17/1989SE |
| K874682 | MMG Catheter Plug W/Drainage Tube CoverKOD · Traditional | 01/27/1988SE |
| K863912 | The MMG 5 in 1 ConnectorBYX · Traditional | 10/27/1986SE |
| K840838 | MMG Connective TubingGAZ · Traditional | 03/30/1984SE |
| K821168 | Disposable Urinary Legbag W/StrapKNX · Traditional | 05/24/1982SE |
| K811469 | MMG Urinary Drainage TubingKNX · Traditional | 06/12/1981SE |
| K800694 | MMG Disposable Urinary Leg BagKNX · Traditional | 05/30/1980SE |
| K791847 | Aspri-LukeBYZ · Traditional | 10/02/1979SE |
| K790279 | Catheter, MMG Latex ExternalKNX · Traditional | 03/06/1979SE |
Questions and answers
When was MMG Uro-Self Catheter cleared by the FDA?
MMG Uro-Self Catheter (K871999) received a 510(k) decision of Substantially Equivalent on August 25, 1987, 91 days after the submission was received.
What is the product code of K871999?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.