Ella Breast Form
510(k) K904085
Ella Breast Form is a Class I device made by Coloplast A/S, cleared under FDA 510(k) K904085 on 31 Oct 1990, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904085 | Date31 Oct 1990 | StatusActive |
Official records
- FDA 510(k) database K904085
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KCZ
- Device class
- Class I
- Regulation
- 21 CFR Part 878.3800
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KCZ (Prosthesis, Breast, External, Used With Adhesive).
- AMOENA AFFINITY MODEL #802 by Coloplast Corp.
- STRAUMANN EXTRAORAL IMPLANT SYSTEM by Straumann USA
- ABC Diamond Attach 10487-02-BH by American Breast Care, LP
- NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT by Coloplast Corp.
- CALSSIQUE OR MYSTIQUE by Dekumed, Kunststofftechnik Degler GmbH
- MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS by Maxol Limited L.C.
- SPENCO BREAST FORMS by Spenco Medical Corp.
- CLASSIQUE by Hemispheres Marketing Co., Ltd.
- COSMET by Great Bay Medical Products, Inc.
- YOURS TRULY ASYMMETRICAL BREAST FORM by Jobst Institute, Inc.