Coloplast - FDA 510(k) Cleared Devices
Recent clearances: Luja female (20051), Virtue Male Sling System with Alexis Wound Retractor Convenience Kit, 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)
15
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Coloplast Gastroenterology & Urology ✕
14 devices
Cleared
Jul 26, 2024
Luja female (20051)
Gastroenterology & Urology
102d
Cleared
Sep 25, 2023
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
Gastroenterology & Urology
90d
Cleared
Aug 25, 2023
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé...
Gastroenterology & Urology
217d
Cleared
Aug 02, 2023
Self-Cath Closed System
Gastroenterology & Urology
224d
Cleared
Dec 02, 2022
Self-Cath and Self-Cath Plus
Gastroenterology & Urology
200d
Cleared
Sep 21, 2022
SpeediCath Flex Set
Gastroenterology & Urology
70d
Cleared
Apr 26, 2022
SpeedCath Compact Male
Gastroenterology & Urology
452d
Cleared
Mar 08, 2022
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus...
Gastroenterology & Urology
449d
Cleared
Nov 13, 2020
SpeediCath Compact Set
Gastroenterology & Urology
228d
Cleared
Nov 02, 2020
SpeediCath Compact Set
Gastroenterology & Urology
384d
Cleared
Jul 30, 2020
SpeediCath Soft
Gastroenterology & Urology
190d
Cleared
Jul 10, 2019
SpeediCath Flex Coude Pro
Gastroenterology & Urology
121d
Cleared
Oct 25, 2018
SpeediCath Standard
Gastroenterology & Urology
268d
Cleared
Feb 02, 2018
SpeediCath Flex Coude Pro
Gastroenterology & Urology
24d