Coloplast Corp.
Medical device manufacturer in Plymouth, MN.
69510(k) clearances
2PMA approvals
3recalls
Device types
- EZD Catheter, Straight 12
- GBM Catheter, Urethral 10
- FAD Stent, Ureteral 7
- FRO Dressing, Wound, Drug 6
- KCZ Prosthesis, Breast, External, Used With… 3
- GBI Material, External Aesthetic Restoration… 3
- MGQ Dressing, Wound And Burn, Hydrogel W/Drug… 3
- OTO Mesh, Surgical, Synthetic, Urogynecologic… 3
- FAQ Bag, Urine Collection, Leg, For External… 2
- KMF Bandage, Liquid 2
- LJE Catheter, Nephrostomy 2
- EZN Dilator, Catheter, Ureteral 2
- EYB Catheter, Ureteral, Gastro-Urology 2
- EXB Collector, Ostomy 1
- FCM Tray, Catheterization, Sterile Urethral… 1
- GEX Powered Laser Surgical Instrument 1
- PWK Instrumentation, Surgical Mesh… 1
- OTP Mesh, Surgical, Synthetic, Urogynecologic… 1
- EZP Rod, Colostomy 1
- NAE Dressing, Wound, Hydrogel Without Drug… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | 10/06/2025SE |
| K251116 | Luja CoudéEZD · Traditional | 06/27/2025SE |
| K250270 | Luja SetEZD · Special | 04/17/2025SE |
| K242049 | SureCath SetEZD · Traditional | 11/26/2024SE |
| K241210 | Luja CoudeEZD · Traditional | 11/21/2024SE |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10…FED · Traditional | 11/12/2024SE |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551)…PAH · Traditional | 10/18/2024SE |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)EZD · Traditional | 07/26/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | 04/15/2024SE |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…FRO · Traditional | 03/22/2024SE |
| K233101 | Luja Coude (20108 Male CH18 - large packaging)EZD · Special | 10/26/2023SE |
| K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience KitOTM · Traditional | 09/25/2023SESK |
| K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10…EZD · Traditional | 08/25/2023SE |
| K223821 | Self-Cath Closed SystemFCM · Traditional | 08/02/2023SE |
| K221401 | Self-Cath and Self-Cath PlusEZD · Traditional | 12/02/2022SE |
| K222059 | SpeediCath Flex SetEZD · Traditional | 09/21/2022SE |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop…FAD · Traditional | 06/08/2022SESK |
| K210250 | SpeedCath Compact MaleEZD · Traditional | 04/26/2022SE |
| K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits…LJE · Traditional | 03/10/2022SESK |
| K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812…EZD · Traditional | 03/08/2022SE |
| K213186 | NovoFlow Reinforced Ureteral StentFAD · Traditional | 02/16/2022SESK |
| K201436 | Vortek Single Loop Ureteral StentFAD · Traditional | 02/25/2021SE |
| K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathLJE · Traditional | 12/17/2020SESK |
| K200820 | SpeediCath Compact SetGBM · Traditional | 11/13/2020SE |
| K192904 | SpeediCath Compact SetGBM · Traditional | 11/02/2020SE |
| K200142 | SpeediCath SoftGBM · Traditional | 07/30/2020SE |
| K201007 | In-Ka Ureteral Balloon Dilatation CatheterEZN · Traditional | 06/11/2020SESK |
| K190620 | SpeediCath Flex Coude ProGBM · Traditional | 07/10/2019SE |
| K182831 | SabreLine and SabreGuard Laser FibersGEX · Traditional | 12/10/2018SE |
| K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral StentFAD · Traditional | 11/06/2018SE |
| K180258 | SpeediCath StandardGBM · Traditional | 10/25/2018SE |
| K182122 | Ureteric CathetersEYB · Traditional | 10/04/2018SE |
| K180057 | Vortek Ureteral Double Loop StentFAD · Traditional | 03/09/2018SE |
| K173501 | Meridian Vaginal Positioning System (VPS)PWK · Traditional | 02/09/2018SE |
| K180070 | SpeediCath Flex Coude ProGBM · Special | 02/02/2018SE |
| K171043 | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric CathetersEYB · Traditional | 12/21/2017SE |
| K170362 | Vortek Hydro-Coated Double Loop Ureteral StentsFAD · Traditional | 11/15/2017SE |
| K170422 | Biosoft Duo Double Loop Ureteral StentsFAD · Traditional | 11/02/2017SE |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy DilatorsEZN · Traditional | 08/17/2017SE |
| K161672 | SpeediCath Flex CoudeGBM · Traditional | 09/29/2016SE |
| K132061 | Restorelle M, Restorelle XLOTO · Special | 08/02/2013SE |
| K122968 | Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015OTO · Traditional | 12/18/2012SE |
| K122440 | Restorelle LOTO · Traditional | 11/19/2012SE |
| K121457 | Speedicath Compact Set (12 FR)GBM · Traditional | 10/02/2012SE |
| K112386 | Exair Anterior and Posterior Prolapse Repair SystemOTP · Special | 09/08/2011SE |
| K072808 | Speedicath CompactGBM · Traditional | 11/09/2007SE |
| K052229 | Coloplast Ostomy Rod, Model 12814EZP · Traditional | 10/13/2006SE |
| K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 In.)FRO · Traditional | 05/17/2004SE |
| K022416 | Contreet Foam Adhesive/Non-AdhesiveFRO · Traditional | 02/03/2003SE |
| K023254 | SpeedicathGBM · Traditional | 01/27/2003SE |
| K013525 | Contreet-H Antimicrobial Hydrocolloid Dressing, Models 9610 (4 X 4 (10 CM X 10CM), 9613…MGQ · Traditional | 10/04/2002SE |
| K991202 | Modification to Woun'DresMGQ · Traditional | 06/04/1999SE |
| K982493 | Compeed Psoriasis DressingFRO · Traditional | 01/28/1999SE |
| K983519 | Comfeel Seasorb DressingKMF · Traditional | 12/30/1998SE |
| K983173 | Biatain Foam Adhesive DressingFRO · Traditional | 12/16/1998SN |
| K983163 | Biatain Foam DressingFRO · Traditional | 12/16/1998SE |
| K983042 | Sween Woun'DresMGQ · Traditional | 11/25/1998SE |
| K973070 | Conveen Easicath SetEZD · Traditional | 11/06/1997SE |
| K971597 | Comfeel Purilon GEL,15G(3900)/COMFEEL Purilon GEL,25G(3903)NAE · Traditional | 07/29/1997SE |
| K955609 | Conveen Urine Bag - SterileFAQ · Traditional | 12/29/1995SE |
| K954857 | Comfeel:Alginate FillerKMF · Traditional | 11/14/1995SN |
| K953783 | Conveen Leg Bag StrapFAQ · Traditional | 09/13/1995SE |
| K923351 | Skin Support Prep PadKOX · Traditional | 09/14/1992SE |
| K921535 | Suoena Affinity (TM) Model #802KCZ · Traditional | 05/11/1992SE |
| K915382 | Amoena Affinity Model #802KCZ · Traditional | 01/14/1992SE |
| K904316 | Nouvelle (TM) Model #901, Sizes 0-12, Left & RightKCZ · Traditional | 10/11/1990SE |
| K864786 | Personally(Tm), Model 241 Sizes 0-12,LEFT & RightGBI · Traditional | 01/08/1987SE |
| K864785 | Amoena Breast FormsGBI · Traditional | 01/08/1987SE |
| K853822 | Amoena Breast FormsGBI · Traditional | 09/30/1985SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0715-2008 | Coloplast Elefant Suction/Irrigation Tubing, Part Number: AST 307, Coloplast Corp.…Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed… | 11/12/2007Terminated |
| Z-0714-2008 | Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy with Tube, Part Numbers:…Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed… | 11/12/2007Terminated |
| Z-0713-2008 | Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP…Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed… | 11/12/2007Terminated |