Coloplast Corp. - FDA 510(k) Cleared Devices
Recent clearances: Luja female, Triad Hydrophilic Wound Dresssing (1964, 2.5 oz), Heylo™ System
56
Total
49
Cleared
0
Denied
FDA 510(k) Regulatory Record - Coloplast Corp. Gastroenterology & Urology ✕
31 devices
Cleared
Oct 28, 2026
Luja female
Gastroenterology & Urology
29d
Cleared
Oct 06, 2025
Heylo™ System
Gastroenterology & Urology
90d
Cleared
Jun 27, 2025
Luja Coudé
Gastroenterology & Urology
77d
Cleared
Apr 17, 2025
Luja Set
Gastroenterology & Urology
77d
Cleared
Nov 26, 2024
SureCath Set
Gastroenterology & Urology
137d
Cleared
Nov 21, 2024
Luja Coude
Gastroenterology & Urology
205d
Cleared
Nov 12, 2024
Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10,...
Gastroenterology & Urology
111d
Cleared
Oct 18, 2024
Altis Single Incision Sling System (519650)
Gastroenterology & Urology
59d
Cleared
Apr 15, 2024
Folysil Silicone Catheter
Gastroenterology & Urology
192d
Cleared
Oct 26, 2023
Luja Coude (20108 Male CH18 - large packaging)
Gastroenterology & Urology
30d
Cleared
Jun 08, 2022
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone...
Gastroenterology & Urology
252d
Cleared
Mar 10, 2022
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy...
Gastroenterology & Urology
262d