COMFEEL:ALGINATE FILLER
FDA 510(k) clearance K954857 · decided 1995-11-14
Clearance details
- K-number
- K954857
- Device name
- COMFEEL:ALGINATE FILLER
- Applicant
- Coloplast Corp.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1995-10-23
- Decision date
- 1995-11-14
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- KMF
- Device class
- 1
- Regulation number
- 880.5090
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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 |