Data / Medical devices / United States / Coloplast Manufacturing Us, LLC
Coloplast Manufacturing Us, LLC: FDA-registered device maker in Minneapolis, MN, United States, 24 510(k) clearances and 2 PMA approvals
Coloplast Manufacturing Us, LLC is registered with the FDA (registration 2125050) in Minneapolis, MN, United States. It lists 18 device types. The FDA files 24 510(k) clearances and 2 PMA approvals under its listings, the newest dated October 18, 2024. 16 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2125050
- Address
- 1601 W River Rd N, Minneapolis, MN, United States, 55411
- Owner or operator
- Coloplast Corp. (8010144)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 28, 2004
- Registered through
- 2026
- Brand names listed
- Altis Single Incision Sling System, Aris Transobturator Kit, Aris Transobturator Sling System, Biosoft Duo Double Loop Stent Kit, Brooks Dilator Set, Digitex Suture Delivery System, Furlow Insertion Tool, Genesis Malleable Penile Prosthesis and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2024 | K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | PAH | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| September 25, 2023 | K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | OTM | Unknown | Coloplast | accessdata.fda.gov |
| February 15, 2023 | K221874 | Altis Single Incision Sling System | PAH | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| June 10, 2022 | K220420 | Saffron Fixation System | PBQ | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| June 8, 2022 | K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits | FAD | Unknown | Coloplast Corp. | accessdata.fda.gov |
| February 16, 2022 | K213186 | NovoFlow Reinforced Ureteral Stent | FAD | Unknown | Coloplast Corp. | accessdata.fda.gov |
| February 25, 2021 | K201436 | Vortek Single Loop Ureteral Stent | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| December 10, 2018 | K182831 | SabreLine and SabreGuard Laser Fibers | GEX | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| November 6, 2018 | K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| March 9, 2018 | K180057 | VORTEK URETERAL DOUBLE LOOP STENT | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| February 9, 2018 | K173501 | Meridian Vaginal Positioning System (VPS) | PWK | Substantially Equivalent | Coloplast | accessdata.fda.gov |
| November 15, 2017 | K170362 | VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| November 2, 2017 | K170422 | BIOSOFT DUO DOUBLE LOOP URETERAL STENTS | FAD | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| February 12, 2014 | K140116 | RESTORELLE Y CONTOUR MESH | OTO | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| August 2, 2013 | K132061 | RESTORELLE M, RESTORELLE XL | OTO | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| March 5, 2013 | K123914 | RESTORELLE Y CONTOUR | OTO | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| November 19, 2012 | K122440 | RESTORELLE L | OTO | Substantially Equivalent | Coloplast Corp. | accessdata.fda.gov |
| November 5, 2012 | K121562 | ALTIS SINGLE INCISION CLING SYSTEM | PAH | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| May 23, 2012 | K120284 | DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX | NEW | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| May 17, 2012 | K112322 | RESTORELLE POLYPROPYLENE Y MESH | OTO | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| February 14, 2012 | K113496 | VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT | OTM | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| June 24, 2011 | K111233 | SUPRIS RETROPUBIC SLING SYSTEM | OTN | Substantially Equivalent | Coloplast A/S | accessdata.fda.gov |
| March 9, 2005 | K050148 | MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT | OTN | Substantially Equivalent | Mentor Corporation | accessdata.fda.gov |
| October 29, 2004 | K040959 | MENTOR GENESIS PENILE PROSTHESIS | FAE | Substantially Equivalent | Mentor Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 19, 2002 | P020003 | COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS | FAF | 12 | July 21, 2026 | accessdata.fda.gov |
| July 14, 2000 | P000006 | TITAN INFLATABLE PENILE PROSTHESIS | FHW | 69 | August 13, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 2, 2024 | 95895 | Class II | Ongoing | Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, A | A possible sterility issue was detected in Coloplast's facility on some Coloplast products. | accessdata.fda.gov |
| March 11, 2024 | 94218 | Class II | Ongoing | Ureteral dilator, REF RBD014 | A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility. | accessdata.fda.gov |
| March 1, 2023 | 91800 | Class II | Ongoing | Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. | accessdata.fda.gov |
| November 9, 2021 | 89029 | Class II | Terminated | Torosa Saline-Filled Testicular Prosthesis (Size Small) | Product is mislabeled for size. | accessdata.fda.gov |
| October 23, 2020 | 86618 | Class II | Terminated | Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis. | Potential increased occurrence of pump fracture over the lifetime of the device. | accessdata.fda.gov |
| March 22, 2016 | 73604 | Class II | Terminated | Self-Cath Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter i | Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 catheters because a small portion of the lot was identified to have missing eyelets. This recall is based upon a complaint Coloplast received regarding a catheter malfunction. | accessdata.fda.gov |
| April 9, 2015 | 70960 | Class II | Terminated | Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis f | Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm. | accessdata.fda.gov |
| September 29, 2014 | 69412 | Class II | Terminated | Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag. | Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled. | accessdata.fda.gov |
| September 8, 2014 | 69279 | Class III | Terminated | Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surr | Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled. | accessdata.fda.gov |
| May 13, 2013 | 65314 | Class II | Terminated | Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The | Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date. | accessdata.fda.gov |
| April 12, 2013 | 64943 | Class II | Terminated | Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark. | Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging. | accessdata.fda.gov |
| March 2, 2012 | 61411 | Not yet classified | Terminated | Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark Restorelle is a ploypropylene mesh that may be used for the repair of abdominal wa | Coloplast is conducting a field correction based on the conclusion that two lots of Restorelle DirectFix Posterior mesh were mislabeled. The incorrect size was printed on the patient label. Specifically the patient label depicts the size as 16x11 cm, however, the correct size is actually 14x15 cm. It is important to note that both the product and box labels | accessdata.fda.gov |
| July 27, 2011 | 59564 | Not yet classified | Terminated | Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm, Sterilized using ethylene oxide; SenSura 19010 Post-Op,ostomy bag with window, 70 mm, Sterilized using ethylene oxi | On July 19, 2011 Coloplast became aware of the failure or routine sterility testing for one lot of SenSuera and Assura Post-Op Ostomy Bags. Based on these results it was determined that all affected lots be recalled and quarantined. This affects lots manufactured and distributed from January 2010 until July 19, 2011. | accessdata.fda.gov |
| April 21, 2011 | 58681 | Not yet classified | Terminated | SureCath Set with Accessories, Coloplast Corp.-MN 06093, Sterile EO., Manufacturer Coloplast -A/S 3050 Denmark. 28022S 1400 SureCath Set,acc CH8 Male,bulk 28023S 1400 Surecath Set,acc CH10 Male,bul 28024S 1400 Surecath S | Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the overall product expiration date. SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies are both packaged with a set of accessories which includes Iodine prep pa | accessdata.fda.gov |
| October 6, 2009 | 53531 | Not yet classified | Terminated | Coloplast Titan OTR Inflatable Penile Prosthesis,18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Manufacturer: Coloplast A/S, 3050 Denmark. Distributed by: Coloplast Corp., Minneapolis, MN 55411 | Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed. The Titan OTR pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps. Coloplast is not recommending product explant because there a | accessdata.fda.gov |
| November 12, 2007 | 45907 | Not yet classified | Terminated | Coloplast Elefant Suction/Irrigation Cannula for Laparoscopy Part Numbers: ASP 105, ASP 150, ASP 145, ASP 180, Coloplast Corp., Minneapolis, MN 55411 | Lack of sterilization assurance: Sterilization of Elefant Suction-Irrigation Devices is not performed according to ISO 11135 standard. | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- All makers of Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- All makers of Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
- All makers of Stent, Ureteral
- All makers of Prosthesis, Penile
- All makers of Retractor
Updated July 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.