Coloplast Corp.
FDA 510(k) & PMA Approved Devices — 27 products
Total Devices27
Categories14
Latest FDA decision2026-08-13
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P000006 | Device, impotence, mechanical/hydraulic | FHW | 2026-08-13 | View |
| PMA | P020003 | Prosthesis, testicular | FAF | 2026-07-21 | View |
| 510(k) | K252140 | Heylo™ System | EXB | 2025-10-06 | View |
| 510(k) | K251116 | Luja Coudé | EZD | 2025-06-27 | View |
| 510(k) | K250270 | Luja Set | EZD | 2025-04-17 | View |
| 510(k) | K242049 | SureCath Set | EZD | 2024-11-26 | View |
| 510(k) | K241210 | Luja Coude | EZD | 2024-11-21 | View |
| 510(k) | K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | FED | 2024-11-12 | View |
| 510(k) | K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | PAH | 2024-10-18 | View |
| 510(k) | K233411 | Folysil Silicone Catheter | EZL | 2024-04-15 | View |
| 510(k) | 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 | 2024-03-22 | View |
| 510(k) | K233101 | Luja Coude (20108 Male CH18 - large packaging) | EZD | 2023-10-26 | View |
| 510(k) | 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 | 2022-06-08 | View |
| 510(k) | K211911 | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets | LJE | 2022-03-10 | View |
| 510(k) | K213186 | NovoFlow Reinforced Ureteral Stent | FAD | 2022-02-16 | View |
| 510(k) | K201436 | Vortek Single Loop Ureteral Stent | FAD | 2021-02-25 | View |
| 510(k) | K201165 | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath | LJE | 2020-12-17 | View |
| 510(k) | K201007 | In-Ka Ureteral Balloon Dilatation Catheter | EZN | 2020-06-11 | View |
| 510(k) | K182831 | SabreLine and SabreGuard Laser Fibers | GEX | 2018-12-10 | View |
| 510(k) | K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | FAD | 2018-11-06 | View |
No matching devices.
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