Coloplast A/S - FDA 510(k) Cleared Devices
Recent clearances: Luja Soft, Altis Single Incision Sling System, Saffron Fixation System
72
Total
69
Cleared
0
Denied
FDA 510(k) Regulatory Record - Coloplast A/S Gastroenterology & Urology ✕
46 devices
Cleared
Jul 07, 2026
Luja Soft
Gastroenterology & Urology
20d
Cleared
Feb 15, 2023
Altis Single Incision Sling System
Gastroenterology & Urology
232d
Cleared
Sep 07, 2018
ReTrace Ureteral Access Sheath
Gastroenterology & Urology
63d
Cleared
Sep 03, 2015
Peristeen Anal Irrigation System
Gastroenterology & Urology
573d
Cleared
Jul 02, 2015
SpeediCath Compact Eve
Gastroenterology & Urology
86d
Cleared
May 27, 2015
Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic...
Gastroenterology & Urology
51d
Cleared
Jan 20, 2015
Speedicath Compact Male
Gastroenterology & Urology
76d
Cleared
Jul 24, 2014
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
Gastroenterology & Urology
142d
Cleared
Jul 09, 2013
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC...
Gastroenterology & Urology
83d
Cleared
Mar 01, 2013
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL...
Gastroenterology & Urology
91d
Cleared
CT
Nov 05, 2012
ALTIS SINGLE INCISION CLING SYSTEM
Gastroenterology & Urology
160d
Cleared
Oct 01, 2012
SPEEDICATH COMPACT SET (12/18 FR)
Gastroenterology & Urology
138d
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