Medical Device Manufacturer · US , Plymouth , MN

Coloplast - FDA 510(k) Cleared Devices

15 submissions · 14 cleared · Since 2018
15
Total
14
Cleared
0
Denied

Coloplast has 14 FDA 510(k) cleared gastroenterology & urology devices. Based in Plymouth, US.

Latest FDA clearance: Jul 2024. Active since 2018.

Browse the complete list of FDA 510(k) cleared gastroenterology & urology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Coloplast
15 devices
1-15 of 15
Cleared Jul 26, 2024
Luja female (20051)
K241028 · EZD
Gastroenterology & Urology · 102d
Cleared Sep 25, 2023
Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
K231891 · OTM
Gastroenterology & Urology · 90d
Cleared Aug 25, 2023
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé...
K230165 · EZD
Gastroenterology & Urology · 217d
Cleared Aug 02, 2023
Self-Cath Closed System
K223821 · FCM
Gastroenterology & Urology · 224d
Cleared Dec 02, 2022
Self-Cath and Self-Cath Plus
K221401 · EZD
Gastroenterology & Urology · 200d
Cleared Sep 21, 2022
SpeediCath Flex Set
K222059 · EZD
Gastroenterology & Urology · 70d
Cleared Apr 26, 2022
SpeedCath Compact Male
K210250 · EZD
Gastroenterology & Urology · 452d
Cleared Mar 08, 2022
SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus...
K203637 · EZD
Gastroenterology & Urology · 449d
Cleared Nov 13, 2020
SpeediCath Compact Set
K200820 · GBM
Gastroenterology & Urology · 228d
Cleared Nov 02, 2020
SpeediCath Compact Set
K192904 · GBM
Gastroenterology & Urology · 384d
Cleared Jul 30, 2020
SpeediCath Soft
K200142 · GBM
Gastroenterology & Urology · 190d
Cleared Jul 10, 2019
SpeediCath Flex Coude Pro
K190620 · GBM
Gastroenterology & Urology · 121d
Cleared Oct 25, 2018
SpeediCath Standard
K180258 · GBM
Gastroenterology & Urology · 268d
Cleared Feb 09, 2018
Meridian Vaginal Positioning System (VPS)
K173501 · PWK
Obstetrics & Gynecology · 88d
Cleared Feb 02, 2018
SpeediCath Flex Coude Pro
K180070 · GBM
Gastroenterology & Urology · 24d
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