Coloplast
FDA 510(k) & PMA Approved Devices — 15 products
Total Devices15
Categories5
Latest FDA decision2024-07-26
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | EZD | 2024-07-26 | View |
| 510(k) | K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | OTM | 2023-09-25 | View |
| 510(k) | K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) | EZD | 2023-08-25 | View |
| 510(k) | K223821 | Self-Cath Closed System | FCM | 2023-08-02 | View |
| 510(k) | K221401 | Self-Cath and Self-Cath Plus | EZD | 2022-12-02 | View |
| 510(k) | K222059 | SpeediCath Flex Set | EZD | 2022-09-21 | View |
| 510(k) | K210250 | SpeedCath Compact Male | EZD | 2022-04-26 | View |
| 510(k) | K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) | EZD | 2022-03-08 | View |
| 510(k) | K200820 | SpeediCath Compact Set | GBM | 2020-11-13 | View |
| 510(k) | K192904 | SpeediCath Compact Set | GBM | 2020-11-02 | View |
| 510(k) | K200142 | SpeediCath Soft | GBM | 2020-07-30 | View |
| 510(k) | K190620 | SpeediCath Flex Coude Pro | GBM | 2019-07-10 | View |
| 510(k) | K180258 | SpeediCath Standard | GBM | 2018-10-25 | View |
| 510(k) | K173501 | Meridian Vaginal Positioning System (VPS) | PWK | 2018-02-09 | View |
| 510(k) | K180070 | SpeediCath Flex Coude Pro | GBM | 2018-02-02 | View |
No matching devices.