Company ยท US
Coloplast Manufacturing US, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2010. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
34recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FHW | Device, Impotence, Mechanical/Hydraulic | 20 |
| EZL | Catheter, Retention Type, Balloon | 3 |
| EZD | Catheter, Straight | 2 |
| EXB | Collector, Ostomy | 1 |
| EZN | Dilator, Catheter, Ureteral | 1 |
| FAE | Prosthesis, Penile | 1 |
| FAF | Prosthesis, Testicular | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 |
| GBM | Catheter, Urethral | 1 |
| NAD | Dressing, Wound, Occlusive | 1 |
| NNW | Bag, Urine Collection, Leg, For External Use, Non-Sterile | 1 |
| OTM | Mesh, Surgical, For Stress Urinary Incontinence, Male | 1 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 26, 2010 | K100878 | SELF CATH CATHETER Coloplast Manufacturing Us, LLC | EZD |
| Feb 1, 2010 | K093112 | DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE Coloplast Manufacturing Us, LLC | GAW |
| Oct 17, 2008 | K082640 | VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM Coloplast Manufacturing Us, LLC | OTM |
| Jun 1, 2007 | K070939 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM Coloplast Manufacturing Us, LLC | FCM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | Coloplast Manufacturing US, LLC X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, Open, Classified |
EZL | K013172 |
| Jan 10, 2025 | Coloplast Manufacturing US, LLC Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA632 Open, Classified |
EZL | K233411 |
| Apr 2, 2024 | Coloplast Manufacturing US, LLC Ureteral dilator, REF RBD014 Open, Classified |
EZN | K170531 |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Apr 12, 2023 | Coloplast Manufacturing US, LLC Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis Open, Classified |
FHW | None listed |
| Nov 9, 2021 | Coloplast Manufacturing US, LLC Torosa Saline-Filled Testicular Prosthesis (Size Small) Terminated |
FHW | None listed |
| Oct 23, 2020 | Coloplast Manufacturing US, LLC 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. Terminated |
FHW | None listed |
| Mar 22, 2016 | Coloplast Manufacturing US, LLC 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 ca Terminated |
EZL | None listed |
| Apr 27, 2015 | Coloplast Manufacturing US, LLC 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 impla Terminated |
FAE | K040959 |
| Oct 30, 2014 | Coloplast Manufacturing US, LLC Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174.
Urine Collection Bag. Terminated |
NNW | None listed |
| Oct 24, 2014 | Coloplast Manufacturing US, LLC 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 ex Terminated |
NAD | None listed |
| Jun 5, 2013 | Coloplast Manufacturing US, LLC 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 th Terminated |
GAM | K120284 |
| May 20, 2013 | Coloplast Manufacturing US, LLC Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark. Terminated |
OTO | K122440 |
| May 2, 2012 | Coloplast Manufacturing US, LLC 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 Terminated |
FTL | K041632 K053361 +1 |
| Sep 9, 2011 | Coloplast Manufacturing US, LLC 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 , Ster Terminated |
EXB | None listed |
| Jun 3, 2011 | Coloplast Manufacturing US, LLC SpeediCath , SpeediCath with Accessories
Coloplast Corp -MN, Sterile R, Manufacturer Coloplast -A/S 3050 Denmark
284821 1400 SpeediCath, acc CH10 Male
284831 1400 SpeediCath, acc CH12 Male
Terminated |
GBM | None listed |
| Jun 3, 2011 | Coloplast Manufacturing US, LLC 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
2 Terminated |
EZD | None listed |
| Dec 27, 2010 | Coloplast Manufacturing US, LLC Coloplast, Saline Filled Testicular Prosthesis, Sterile R, Manufacturer Coloplast A/S 3050 Denmark.
Catalogue Number Description Part Number
450-1323 Extra Small 520600
450-1325 Sma Terminated |
FAF | None listed |
| Nov 10, 2009 | Coloplast Manufacturing US, LLC 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 Cor Terminated |
FHW | None listed |