FDA 510(k) Applications Submitted by Coloplast
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200142 |
01/22/2020 |
SpeediCath Soft |
Coloplast |
| K210250 |
01/29/2021 |
SpeedCath Compact Male |
Coloplast |
| K190620 |
03/11/2019 |
SpeediCath Flex Coude Pro |
Coloplast |
| K203637 |
12/14/2020 |
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) |
Coloplast |
| K173501 |
11/13/2017 |
Meridian Vaginal Positioning System (VPS) |
Coloplast |
| K231891 |
06/27/2023 |
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit |
Coloplast |
| K200820 |
03/30/2020 |
SpeediCath Compact Set |
Coloplast |
| K192904 |
10/15/2019 |
SpeediCath Compact Set |
Coloplast |
| K180258 |
01/30/2018 |
SpeediCath Standard |
Coloplast |
| K221401 |
05/16/2022 |
Self-Cath and Self-Cath Plus |
Coloplast |
| K222059 |
07/13/2022 |
SpeediCath Flex Set |
Coloplast |
| K223821 |
12/21/2022 |
Self-Cath Closed System |
Coloplast |
| K180070 |
01/09/2018 |
SpeediCath Flex Coude Pro |
Coloplast |
| K230165 |
01/20/2023 |
Luja CoudΘ (20118 Male CH8 - small packaging (Pocket size)), Luja CoudΘ (20111 Male CH10 - small packaging (Pocket size)), Luja CoudΘ (20112 Male CH12 - small packaging (Pocket size)), Luja CoudΘ (20114 Male CH14 - small packaging (Pocket size)), Luja Cou |
Coloplast |
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