Plymouth, MN, US · 27 510(k) clearances · 24 PMAs
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EZD | Catheter, Straight | Class II | Gastroenterology, Urology | 11 | 2025-06-27 |
| FAD | Stent, Ureteral | Class II | Gastroenterology, Urology | 3 | 2022-06-08 |
| GBM | Catheter, Urethral | Class II | Gastroenterology, Urology | 3 | 2020-11-13 |
| LJE | — | — | — | 2 | 2022-03-10 |
| EXB | Collector, Ostomy | Class I | Gastroenterology, Urology | 1 | 2025-10-06 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2024-11-12 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | Class II | General, Plastic Surgery | 1 | 2024-10-18 |
| EZL | Catheter, Retention Type, Balloon | Class II | Gastroenterology, Urology | 1 | 2024-04-15 |
| FRO | Dressing, Wound, Drug | Unclassified | Unknown | 1 | 2024-03-22 |
| OTM | Mesh, Surgical, For Stress Urinary Incontinence, Male | Class II | General, Plastic Surgery | 1 | 2023-09-25 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Class II | Gastroenterology, Urology | 1 | 2023-08-02 |
| EZN | Dilator, Catheter, Ureteral | Class II | Gastroenterology, Urology | 1 | 2020-06-11 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-08-13 | P000006-S076 | Titan Inflatable Penile Prosthesis | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2026-07-21 | P020003-S012 | Torosa Saline Filled Testicular Prosthesis | 30-Day Notice | FAF | Prosthesis, Testicular | Gastroenterology, Urology |
| 2026-07-21 | P000006-S074 | Titan Inflatable Penile Prosthesis | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2026-07-20 | P000006-S075 | Titan Inflatable Penile Prosthesis | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2026-06-02 | P000006-S072 | Titan Inflatable Penile Prosthesis (IPP) | Normal 180 Day Track | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2025-08-14 | P000006-S071 | Titan Inflatable Penile Prosthesis | Real-Time Process | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2025-05-28 | P000006-S070 | Titan Inflatable Penile Prosthesis | Normal 180 Day Track No User Fee | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2024-10-02 | P000006-S069 | Titan Inflatable Penile Prosthesis (IPP) | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2024-07-09 | P000006-S068 | Titan Inflatable Penile Prosthesis (IPP) | Real-Time Process | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2024-02-05 | P000006-S067 | Titan Inflatable Penile Prosthesis (IPP) | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2023-03-03 | P000006-S064 | Titan Inflatable Penile Prosthesis (IPP) | Real-Time Process | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2023-02-15 | P000006-S066 | Titan Inflatable Penile Prosthesis (IPP) | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2023-01-12 | P000006-S065 | Titan Inflatable Penile Prosthesis (IPP) | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2022-12-01 | P000006-S063 | Titan Inflatable Penile Prosthesis (IPP) | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2022-09-16 | P020003-S011 | Coloplast Saline-Filled Testicular Prosthesis (Torosa) | 30-Day Notice | FAF | Prosthesis, Testicular | Gastroenterology, Urology |
| 2022-08-24 | P020003-S010 | Coloplast Saline-Filled Testicular Prosthesis (Torosa) | 30-Day Notice | FAF | Prosthesis, Testicular | Gastroenterology, Urology |
| 2022-08-24 | P000006-S062 | Titan Inflatable Penile Prosthesis (IPP) | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2022-04-15 | P000006-S061 | Titan Inflatable Penile Prosthesis (IPP) | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2021-12-22 | P000006-S060 | TITAN INFLATABLE PENILE PROSTHESIS | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2021-01-08 | P000006-S059 | Titan Inflatable Penile Prosthesis | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2020-12-07 | P000006-S058 | Titan Inflatable Penile Prosthesis | Real-Time Process | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2020-10-01 | P000006-S057 | Titan Inflatable Penile Prosthesis | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2020-07-10 | P000006-S054 | Titan Inflatable Penile Prosthesis (IPP) | Real-Time Process | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| 2020-06-05 | P000006-S056 | Titan Inflatable Penile Prosthesis (IPP) | 30-Day Notice | FHW | Device, Impotence, Mechanical/Hydraulic | Gastroenterology, Urology |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-06 | K252140 | Heylo System | EXB | Class I | Gastroenterology, Urology |
| 2025-06-27 | K251116 | Luja Coudé | EZD | Class II | Gastroenterology, Urology |
| 2025-04-17 | K250270 | Luja Set | EZD | Class II | Gastroenterology, Urology |
| 2024-11-26 | K242049 | SureCath Set | EZD | Class II | Gastroenterology, Urology |
| 2024-11-21 | K241210 | Luja Coude | EZD | Class II | Gastroenterology, Urology |
| 2024-11-12 | K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | FED | Class II | Gastroenterology, Urology |
| 2024-10-18 | K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | PAH | Class II | General, Plastic Surgery |
| 2024-07-26 | K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | EZD | Class II | Gastroenterology, Urology |
| 2024-04-15 | K233411 | Folysil Silicone Catheter | EZL | Class II | Gastroenterology, Urology |
| 2024-03-22 | K231953 | Biatain 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 Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) | FRO | Unclassified | Unknown |
| 2023-10-26 | K233101 | Luja Coude (20108 Male CH18 - large packaging) | EZD | Class II | Gastroenterology, Urology |
| 2023-09-25 | K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | OTM | Class II | General, Plastic Surgery |
| 2023-08-25 | K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) | EZD | Class II | Gastroenterology, Urology |
| 2023-08-02 | K223821 | Self-Cath Closed System | FCM | Class II | Gastroenterology, Urology |
| 2022-12-02 | K221401 | Self-Cath and Self-Cath Plus | EZD | Class II | Gastroenterology, Urology |
| 2022-09-21 | K222059 | SpeediCath Flex Set | EZD | Class II | Gastroenterology, Urology |
| 2022-06-08 | 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 | Class II | Gastroenterology, Urology |
| 2022-04-26 | K210250 | SpeedCath Compact Male | EZD | Class II | Gastroenterology, Urology |
| 2022-03-10 | K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets | LJE | — | — |
| 2022-03-08 | K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) | EZD | Class II | Gastroenterology, Urology |
| 2022-02-16 | K213186 | NovoFlow Reinforced Ureteral Stent | FAD | Class II | Gastroenterology, Urology |
| 2021-02-25 | K201436 | Vortek Single Loop Ureteral Stent | FAD | Class II | Gastroenterology, Urology |
| 2020-12-17 | K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | LJE | — | — |
| 2020-11-13 | K200820 | SpeediCath Compact Set | GBM | Class II | Gastroenterology, Urology |
| 2020-11-02 | K192904 | SpeediCath Compact Set | GBM | Class II | Gastroenterology, Urology |
| 2020-07-30 | K200142 | SpeediCath Soft | GBM | Class II | Gastroenterology, Urology |
| 2020-06-11 | K201007 | In-Ka Ureteral Balloon Dilatation Catheter | EZN | Class II | Gastroenterology, Urology |