KCZ · Prosthesis, Breast, External, Used With Adhesive
General, Plastic Surgery · 21 CFR 878.3800 · Class 1
Overview
| Product Code | KCZ |
|---|---|
| Device Name | Prosthesis, Breast, External, Used With Adhesive |
| Regulation | 21 CFR 878.3800 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990458 | STRAUMANN EXTRAORAL IMPLANT SYSTEM | Straumann USA | Apr 16, 1999 | SESE |
| K951324 | MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS | Maxol Limited L.C. | May 26, 1995 | SESE |
| K933465 | COSMET | Great Bay Medical Products, Inc. | Jul 20, 1994 | SESE |
| K932978 | CALSSIQUE OR MYSTIQUE | Dekumed, Kunststofftechnik Degler GmbH | Dec 22, 1993 | SESE |
| K932899 | CLASSIQUE | Hemispheres Marketing Co. , Ltd. | Dec 16, 1993 | SESE |
| K933668 | ALMOST U, INC. BREAST PROSTHESIS | Almost U., Inc. | Dec 10, 1993 | SESE |
| K921535 | SUOENA AFFINITY (TM) MODEL #802 | Coloplast Corp. | May 11, 1992 | SESE |
| K915382 | AMOENA AFFINITY MODEL #802 | Coloplast Corp. | Jan 14, 1992 | SESE |
| K911247 | YOURS TRULY ASYMMETRICAL BREAST FORM | Jobst Institute, Inc. | Mar 29, 1991 | SESE |
| K904085 | ELLA BREAST FORM | Coloplast A/S | Oct 31, 1990 | SESE |
| K904316 | NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT | Coloplast Corp. | Oct 11, 1990 | SESE |
| K904086 | DISCRENE SELF-SUPPORTING BREAST FORM | Coloplast A/S | Oct 2, 1990 | SESE |
| K896533 | SPENCO BREAST FORMS | Spenco Medical Corp. | Dec 13, 1989 | SESE |
Top Applicants
- Coloplast Corp. — 3 clearances
- Coloplast A/S — 2 clearances
- Straumann USA — 1 clearance
- Spenco Medical Corp. — 1 clearance
- Maxol Limited L.C. — 1 clearance
