ClearanceBrief
Company · US

Coloplast Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2025. Name variants (Inc, Corp, punctuation) are merged.

69510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
EZDCatheter, Straight12
GBMCatheter, Urethral10
FADStent, Ureteral7
FRODressing, Wound, Drug6
FQHLavage, Jet3
GBIMaterial, External Aesthetic Restoration, Used With Adhesive3
KCZProsthesis, Breast, External, Used With Adhesive3
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic3
OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed3
EYBCatheter, Ureteral, Gastro-Urology2
EZNDilator, Catheter, Ureteral2
FAQBag, Urine Collection, Leg, For External Use, Sterile2
KMFBandage, Liquid2
LJECatheter, Nephrostomy2
EXBCollector, Ostomy1
EZLCatheter, Retention Type, Balloon1
EZPRod, Colostomy1
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)1
FEDEndoscopic Access Overtube, Gastroenterology-Urology1
GEXPowered Laser Surgical Instrument1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 6, 2025K252140Heylo™ System
Coloplast Corp.
EXB
Jun 27, 2025K251116Luja Coudé
Coloplast Corp.
EZD
Apr 17, 2025K250270Luja Set
Coloplast Corp.
EZD
Nov 26, 2024K242049SureCath Set
Coloplast Corp.
EZD
Nov 21, 2024K241210Luja Coude
Coloplast Corp.
EZD
Nov 12, 2024K242173Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)
Coloplast Corp.
FED
Oct 18, 2024K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (
Coloplast Corp.
PAH
Jul 26, 2024K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)
Coloplast
EZD
Apr 15, 2024K233411Folysil Silicone Catheter
Coloplast Corp.
EZL
Mar 22, 2024K231953Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fi
Coloplast Corp.
FRO
Oct 26, 2023K233101Luja Coude (20108 Male CH18 - large packaging)
Coloplast Corp.
EZD
Sep 25, 2023K231891Virtue Male Sling System with Alexis Wound Retractor Convenience Kit
Coloplast
OTM
Aug 25, 2023K230165Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)
Coloplast
EZD
Aug 2, 2023K223821Self-Cath Closed System
Coloplast
FCM
Dec 2, 2022K221401Self-Cath and Self-Cath Plus
Coloplast
EZD
Sep 21, 2022K222059SpeediCath Flex Set
Coloplast
EZD
Jun 8, 2022K213185ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Sten
Coloplast Corp.
FAD
Apr 26, 2022K210250SpeedCath Compact Male
Coloplast
EZD
Mar 10, 2022K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
Coloplast Corp.
LJE
Mar 8, 2022K203637SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814)
Coloplast
EZD
Feb 16, 2022K213186NovoFlow Reinforced Ureteral Stent
Coloplast Corp.
FAD
Feb 25, 2021K201436Vortek Single Loop Ureteral Stent
Coloplast Corp.
FAD
Dec 17, 2020K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
Coloplast Corp.
LJE
Nov 13, 2020K200820SpeediCath Compact Set
Coloplast
GBM
Nov 2, 2020K192904SpeediCath Compact Set
Coloplast
GBM
Jul 30, 2020K200142SpeediCath Soft
Coloplast
GBM
Jun 11, 2020K201007In-Ka Ureteral Balloon Dilatation Catheter
Coloplast Corp.
EZN
Jul 10, 2019K190620SpeediCath Flex Coude Pro
Coloplast
GBM
Dec 10, 2018K182831SabreLine and SabreGuard Laser Fibers
Coloplast Corp.
GEX
Nov 6, 2018K180469ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
Coloplast Corp.
FAD
Oct 25, 2018K180258SpeediCath Standard
Coloplast
GBM
Oct 4, 2018K182122Ureteric Catheters
Coloplast Corp.
EYB
Mar 9, 2018K180057VORTEK URETERAL DOUBLE LOOP STENT
Coloplast Corp.
FAD
Feb 9, 2018K173501Meridian Vaginal Positioning System (VPS)
Coloplast
PWK
Feb 2, 2018K180070SpeediCath Flex Coude Pro
Coloplast
GBM
Dec 21, 2017K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
Coloplast Corp.
EYB
Nov 15, 2017K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
Coloplast Corp.
FAD
Nov 2, 2017K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
Coloplast Corp.
FAD
Aug 17, 2017K170531Ureteral Dilators and Percutaneous Nephrostomy Dilators
Coloplast Corp.
EZN
Sep 29, 2016K161672SpeediCath Flex Coude
Coloplast Corp.
GBM
Aug 2, 2013K132061RESTORELLE M, RESTORELLE XL
Coloplast Corp.
OTO
Dec 18, 2012K122968NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015
Coloplast Corp.
OTO
Nov 19, 2012K122440RESTORELLE L
Coloplast Corp.
OTO
Oct 2, 2012K121457SPEEDICATH COMPACT SET (12 FR)
Coloplast Corp.
GBM
Sep 8, 2011K112386EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
Coloplast Corp.
OTP
Nov 9, 2007K072808SPEEDICATH COMPACT
Coloplast Corp.
GBM
Oct 13, 2006K052229COLOPLAST OSTOMY ROD, MODEL 12814
Coloplast Corp.
EZP
May 17, 2004K033869CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
Coloplast Corp.
FRO
Feb 3, 2003K022416CONTREET FOAM ADHESIVE/NON-ADHESIVE
Coloplast Corp.
FRO
Jan 27, 2003K023254SPEEDICATH
Coloplast Corp.
GBM

Newest 50 of 69.

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 3, 2008Coloplast Corp
Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp., Minneapolis, MN 55411
Terminated		 FQHNone listed
Apr 3, 2008Coloplast Corp
Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers: ASP 165, ASP 170, Coloplast Corp., Minneapolis, MN 55411
Terminated		 FQHNone listed
Apr 3, 2008Coloplast Corp
Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP 150, ASP 145, ASP 180, Coloplast Corp., Minneapolis, MN 55411
Terminated		 FQHNone listed
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