FDA product code GEE: Brush, Biopsy, General & Plastic Surgery
GEE is the FDA product code for brush, biopsy, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under GEE, from 7 different applicants. The average 510(k) review took 35 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Brush, Biopsy, General & Plastic Surgery |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Top GEE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Co-Medical, Inc. | 1 | 1985-10-18 |
| Premier Dental Products Co. | 1 | 1984-06-08 |
| Van-Tec, Inc. | 1 | 1982-09-14 |
| American Endoscopy, Inc. | 1 | 1982-03-05 |
| Medi-Spec | 1 | 1981-10-26 |
2 more applicants have GEE clearances. See the full list in Caduvo.
Most recent GEE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K854003 | Co-Medical, Inc. | STERILE SOFT TISSUE BIOPSY NEEDLE | 1985-10-18 | 18 |
| K841008 | Premier Dental Products Co. | BIOPSY PUNCH, VARIOUS | 1984-06-08 | 91 |
| K822490 | Van-Tec, Inc. | DEFLECTING CYTOLOGY BRUSH | 1982-09-14 | 27 |
| K820259 | American Endoscopy, Inc. | STERILE CYTOLOGY BRUSHES | 1982-03-05 | 32 |
| K812694 | Medi-Spec | WHISK-R | 1981-10-26 | 34 |
Recalls for GEE devices
openFDA lists no recalls for product code GEE.
Frequently asked questions
What is FDA product code GEE?
GEE is the FDA product code for brush, biopsy, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is GEE?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GEE?
Across 7 cleared submissions the average was 35 days from receipt to decision (median 32).
Which companies have the most GEE clearances?
Co-Medical, Inc. (1); Premier Dental Products Co. (1); Van-Tec, Inc. (1); American Endoscopy, Inc. (1); Medi-Spec (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GEE
- Run a recall and safety report across every GEE manufacturer
- Watch product code GEE 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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