FDA product code GBI: Material, External Aesthetic Restoration, Used With Adhesive
GBI is the FDA product code for material, external aesthetic restoration, used with adhesive. It is a Class I device, regulated under 21 CFR 878.3800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 17 510(k) submissions under GBI, from 13 different applicants. The average 510(k) review took 61 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Material, External Aesthetic Restoration, Used With Adhesive |
| Device class | Class I |
| Regulation | 21 CFR 878.3800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GBI clearance
Top GBI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coloplast Corp. | 3 | 1987-01-08 |
| Delaware Prosthetics, Inc. | 3 | 1983-12-19 |
| Factor, Ii, Inc. | 1 | 1988-06-01 |
| Pacific Prosthetics, Inc. | 1 | 1987-10-29 |
| Roseburg SA | 1 | 1987-07-21 |
8 more applicants have GBI clearances. See the full list in Caduvo.
Most recent GBI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880329 | Factor, Ii, Inc. | FACTOR II PROSTHETIC SILICONE ELASTOMER | 1988-06-01 | 127 |
| K874279 | Pacific Prosthetics, Inc. | AHH NATURAL BREAST FORM | 1987-10-29 | 9 |
| K872714 | Roseburg SA | S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY | 1987-07-21 | 11 |
| K864785 | Coloplast Corp. | AMOENA BREAST FORMS | 1987-01-08 | 31 |
| K864786 | Coloplast Corp. | PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT | 1987-01-08 | 31 |
Recalls for GBI devices
openFDA lists no recalls for product code GBI.
Frequently asked questions
What is FDA product code GBI?
GBI is the FDA product code for material, external aesthetic restoration, used with adhesive. It is a Class I device, regulated under 21 CFR 878.3800 and reviewed by the General and Plastic Surgery panel.
What device class is GBI?
Class I, regulation 21 CFR 878.3800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBI?
Across 17 cleared submissions the average was 61 days from receipt to decision (median 37).
Which companies have the most GBI clearances?
Coloplast Corp. (3); Delaware Prosthetics, Inc. (3); Factor, Ii, Inc. (1); Pacific Prosthetics, Inc. (1); Roseburg SA (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GBI
- Run a recall and safety report across every GBI manufacturer
- Watch product code GBI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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