Coloplast
Coloplast holds FDA 510(k) medical device clearances, first cleared 2018, most recent 2024.
Top product codes for Coloplast
Recent clearances by Coloplast
- K241028 — Luja female (4 models)
- K231891 — Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
- 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)
- K223821 — Self-Cath Closed System
- K221401 — Self-Cath and Self-Cath Plus
- K222059 — SpeediCath Flex Set
- K210250 — SpeedCath Compact Male
- K203637 — SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
- K200820 — SpeediCath Compact Set
- K192904 — SpeediCath Compact Set
- K200142 — SpeediCath Soft
- K190620 — SpeediCath Flex Coude Pro
- K180258 — SpeediCath Standard
- K173501 — Meridian Vaginal Positioning System (VPS)
- K180070 — SpeediCath Flex Coude Pro
Data sourced from openFDA. This site is unofficial and independent of the FDA.