Material, External Aesthetic Restoration, Used With Adhesive
The Material, External Aesthetic Restoration, Used With Adhesive (product code GBI) is an external prosthetic or restorative material adhered to the body surface to restore or simulate normal anatomical appearance, used in conjunction with a medical adhesive for patients who have undergone surgery or sustained tissue loss. It is classified as FDA Class 1, posing the lowest level of risk, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 878.3800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GBI
- 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 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K880329 | FACTOR II PROSTHETIC SILICONE ELASTOMER | Jun 01, 1988 | Substantially Equivalent | Factor, Ii, Inc. |
| K874279 | AHH NATURAL BREAST FORM | Oct 29, 1987 | Substantially Equivalent | Pacific Prosthetics, Inc. |
| K872714 | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | Jul 21, 1987 | Substantially Equivalent | Roseburg SA |
| K864786 | PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT | Jan 08, 1987 | Substantially Equivalent | Coloplast Corp. |
| K864785 | AMOENA BREAST FORMS | Jan 08, 1987 | Substantially Equivalent | Coloplast Corp. |
| K853822 | AMOENA BREAST FORMS | Sep 30, 1985 | Substantially Equivalent | Coloplast Corp. |
| K851668 | PROSTHESIS OR SURGICAL PADS | Jun 04, 1985 | Substantially Equivalent | Virginia Hall, Inc. |
| K842765 | SILIMED BREAST FORM | Aug 17, 1984 | Substantially Equivalent | Sil-Med Corp. |
| K841559 | CONFORMA | Jul 17, 1984 | Substantially Equivalent | Beiersdorf, Inc. |
| K841171 | TRILICON BREASE PROSTHESIS DIFFERENT | Apr 25, 1984 | Substantially Equivalent | Baurs Krey Assoc., Inc. |
| K832151 | PDM SILOXANE PROSTHETIC ORBIT | Dec 19, 1983 | Substantially Equivalent | Delaware Prosthetics, Inc. |
| K832153 | PDM SILOXANE PROSTHETIC NOSE | Dec 09, 1983 | Substantially Equivalent | Delaware Prosthetics, Inc. |
| K832152 | PDM SILOXANE PROSTHETIC EAR | Dec 09, 1983 | Substantially Equivalent | Delaware Prosthetics, Inc. |
| K831831 | TRULIFE SILICONE BREAST FORM | Jun 30, 1983 | Substantially Equivalent | Medeering, Ltd. |
| K813416 | EXTERNAL BREAST PROSTHESIS | Jan 18, 1982 | Substantially Equivalent | Surgical Appliance Industries, Inc. |
| K792372 | IPOS BREAST PROSTHESIS | Dec 19, 1979 | Substantially Equivalent | Ipos KG |
| K770359 | IMPLANTING OF POLYACRYLIC FIBERS | Apr 08, 1977 | Substantially Equivalent | Allan V. Marse |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.