FDA 510(k) Applications Submitted by Coloplast Corp

FDA 510(k) Number Submission Date Device Name Applicant
K211911 06/21/2021 Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets Coloplast Corp
K233411 10/06/2023 Folysil Silicone Catheter Coloplast Corp
K180057 01/08/2018 VORTEK URETERAL DOUBLE LOOP STENT Coloplast Corp
K170362 02/06/2017 VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS Coloplast Corp
K170422 02/13/2017 BIOSOFT DUO DOUBLE LOOP URETERAL STENTS Coloplast Corp
K180469 02/21/2018 ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent Coloplast Corp
K170531 02/22/2017 Ureteral Dilators and Percutaneous Nephrostomy Dilators Coloplast Corp
K171043 04/07/2017 Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters Coloplast Corp
K201007 04/17/2020 In-Ka Ureteral Balloon Dilatation Catheter Coloplast Corp
K201165 05/01/2020 In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath Coloplast Corp
K201436 06/01/2020 Vortek Single Loop Ureteral Stent Coloplast Corp
K182122 08/06/2018 Ureteric Catheters Coloplast Corp
K182831 10/09/2018 SabreLine and SabreGuard Laser Fibers Coloplast Corp
K213185 09/29/2021 ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits Coloplast Corp
K213186 09/29/2021 NovoFlow Reinforced Ureteral Stent Coloplast Corp
K242473 08/20/2024 Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) Coloplast Corp
K241210 04/30/2024 Luja Coude Coloplast Corp
K233101 09/26/2023 Luja Coude (20108 Male CH18 - large packaging) Coloplast Corp
K250270 01/30/2025 Luja Set Coloplast Corp
K242049 07/12/2024 SureCath Set Coloplast Corp


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