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)
FDA 510(k) clearance K231953 · decided 2024-03-22
Clearance details
- K-number
- K231953
- Device name
- 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)
- Applicant
- Coloplast Corp.
- Decision
- Substantially Equivalent
- Date received
- 2023-06-30
- Decision date
- 2024-03-22
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- FRO
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Plymouth, MN, 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/S074) | Coloplast Corp. | 2026-07-21 |
| Torosa Saline Filled Testicular Prosthesis (P020003/S012) | Coloplast Corp. | 2026-07-21 |
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| Titan Inflatable Penile Prosthesis (IPP) (P000006/S072) | Coloplast Corp. | 2026-06-02 |
| 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 |