AMOENA BREAST FORMS
FDA 510(k) clearance K864785 · decided 1987-01-08
Clearance details
- K-number
- K864785
- Device name
- AMOENA BREAST FORMS
- Applicant
- Coloplast Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-08
- Decision date
- 1987-01-08
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- GBI
- Device class
- 1
- Regulation number
- 878.3800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FACTOR II PROSTHETIC SILICONE ELASTOMER (K880329) | Factor, Ii, Inc. | 1988-06-01 |
| AHH NATURAL BREAST FORM (K874279) | Pacific Prosthetics, Inc. | 1987-10-29 |
| S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY (K872714) | Roseburg SA | 1987-07-21 |
| PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT (K864786) | Coloplast Corp. | 1987-01-08 |
| AMOENA BREAST FORMS (K853822) | Coloplast Corp. | 1985-09-30 |
| PROSTHESIS OR SURGICAL PADS (K851668) | Virginia Hall, Inc. | 1985-06-04 |
| SILIMED BREAST FORM (K842765) | Sil-Med Corp. | 1984-08-17 |
| CONFORMA (K841559) | Beiersdorf, Inc. | 1984-07-17 |
| TRILICON BREASE PROSTHESIS DIFFERENT (K841171) | Baurs Krey Assoc., Inc. | 1984-04-25 |
| PDM SILOXANE PROSTHETIC ORBIT (K832151) | Delaware Prosthetics, Inc. | 1983-12-19 |
| PDM SILOXANE PROSTHETIC EAR (K832152) | Delaware Prosthetics, Inc. | 1983-12-09 |
| PDM SILOXANE PROSTHETIC NOSE (K832153) | Delaware Prosthetics, Inc. | 1983-12-09 |
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 |