GBI · Material, External Aesthetic Restoration, Used With Adhesive
General, Plastic Surgery · 21 CFR 878.3800 · Class 1
Overview
| Product Code | GBI |
|---|---|
| Device Name | Material, External Aesthetic Restoration, 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 (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880329 | FACTOR II PROSTHETIC SILICONE ELASTOMER | Factor, Ii, Inc. | Jun 1, 1988 | SESE |
| K874279 | AHH NATURAL BREAST FORM | Pacific Prosthetics, Inc. | Oct 29, 1987 | SESE |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Roseburg SA | Jul 21, 1987 | SESE |
| K864786 | PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT | Coloplast Corp. | Jan 8, 1987 | SESE |
| K864785 | AMOENA BREAST FORMS | Coloplast Corp. | Jan 8, 1987 | SESE |
| K853822 | AMOENA BREAST FORMS | Coloplast Corp. | Sep 30, 1985 | SESE |
| K851668 | PROSTHESIS OR SURGICAL PADS | Virginia Hall, Inc. | Jun 4, 1985 | SESE |
| K842765 | SILIMED BREAST FORM | Sil-Med Corp. | Aug 17, 1984 | SESE |
| K841559 | CONFORMA | Beiersdorf, Inc. | Jul 17, 1984 | SESE |
| K841171 | TRILICON BREASE PROSTHESIS DIFFERENT | Baurs Krey Assoc., Inc. | Apr 25, 1984 | SESE |
| K832151 | PDM SILOXANE PROSTHETIC ORBIT | Delaware Prosthetics, Inc. | Dec 19, 1983 | SESE |
| K832153 | PDM SILOXANE PROSTHETIC NOSE | Delaware Prosthetics, Inc. | Dec 9, 1983 | SESE |
| K832152 | PDM SILOXANE PROSTHETIC EAR | Delaware Prosthetics, Inc. | Dec 9, 1983 | SESE |
| K831831 | TRULIFE SILICONE BREAST FORM | Medeering, Ltd. | Jun 30, 1983 | SESE |
| K813416 | EXTERNAL BREAST PROSTHESIS | Surgical Appliance Industries, Inc. | Jan 18, 1982 | SESE |
| K792372 | IPOS BREAST PROSTHESIS | Ipos KG | Dec 19, 1979 | SESE |
| K770359 | IMPLANTING OF POLYACRYLIC FIBERS | Allan V. Marse | Apr 8, 1977 | SESE |
Top Applicants
- Coloplast Corp. — 3 clearances
- Delaware Prosthetics, Inc. — 3 clearances
- Allan V. Marse — 1 clearance
- Baurs Krey Assoc., Inc. — 1 clearance
- Beiersdorf, Inc. — 1 clearance
