Folysil Silicone Catheter
FDA 510(k) clearance K233411 · decided 2024-04-15
Clearance details
- K-number
- K233411
- Device name
- Folysil Silicone Catheter
- Applicant
- Coloplast Corp.
- Decision
- Substantially Equivalent
- Date received
- 2023-10-06
- Decision date
- 2024-04-15
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- EZL
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, recall (Z-0844-2025) | Coloplast Manufacturing US, LLC | 2025-01-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Titan Inflatable Penile Prosthesis (P000006/S071) | Coloplast Corp. | 2025-08-14 |
| Titan Inflatable Penile Prosthesis (P000006/S070) | Coloplast Corp. | 2025-05-28 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S069) | Coloplast Corp. | 2024-10-02 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S068) | Coloplast Corp. | 2024-07-09 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S067) | Coloplast Corp. | 2024-02-05 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S064) | Coloplast Corp. | 2023-03-03 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S066) | Coloplast Corp. | 2023-02-15 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S065) | Coloplast Corp. | 2023-01-12 |