Prosthesis, Breast, External, Used With Adhesive
An external breast prosthesis used with adhesive is a non-implanted device worn externally by mastectomy patients to restore breast contour and appearance, attached to the chest wall using a biocompatible adhesive rather than being surgically implanted. It is classified as an FDA Class 1 device, the lowest risk category, subject only to general controls and not requiring premarket clearance. Product code KCZ is regulated under 21 CFR 878.3800 in the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KCZ
- Device Class
- FDA class 1
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K990458 | STRAUMANN EXTRAORAL IMPLANT SYSTEM | Apr 16, 1999 | Substantially Equivalent | Straumann USA |
| K951324 | MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS | May 26, 1995 | Substantially Equivalent | Maxol Limited L.C. |
| K933465 | COSMET | Jul 20, 1994 | Substantially Equivalent | Great Bay Medical Products, Inc. |
| K932978 | CALSSIQUE OR MYSTIQUE | Dec 22, 1993 | Substantially Equivalent | Dekumed, Kunststofftechnik Degler GmbH |
| K932899 | CLASSIQUE | Dec 16, 1993 | Substantially Equivalent | Hemispheres Marketing Co. , Ltd. |
| K933668 | ALMOST U, INC. BREAST PROSTHESIS | Dec 10, 1993 | Substantially Equivalent | Almost U., Inc. |
| K921535 | SUOENA AFFINITY (TM) MODEL #802 | May 11, 1992 | Substantially Equivalent | Coloplast Corp. |
| K915382 | AMOENA AFFINITY MODEL #802 | Jan 14, 1992 | Substantially Equivalent | Coloplast Corp. |
| K911247 | YOURS TRULY ASYMMETRICAL BREAST FORM | Mar 29, 1991 | Substantially Equivalent | Jobst Institute, Inc. |
| K904085 | ELLA BREAST FORM | Oct 31, 1990 | Substantially Equivalent | Coloplast A/S |
| K904316 | NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT | Oct 11, 1990 | Substantially Equivalent | Coloplast Corp. |
| K904086 | DISCRENE SELF-SUPPORTING BREAST FORM | Oct 02, 1990 | Substantially Equivalent | Coloplast A/S |
| K896533 | SPENCO BREAST FORMS | Dec 13, 1989 | Substantially Equivalent | Spenco Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.