FDA product code GEO: File, Surgical, General & Plastic Surgery
GEO is the FDA product code for file, surgical, 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 2 510(k) submissions under GEO, from 2 different applicants. The average 510(k) review took 24 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | File, Surgical, 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 |
Compare with all 510(k) review times · Search every GEO clearance
Top GEO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med-Tool, Inc. | 1 | 1984-11-20 |
| Unisplint Corp. | 1 | 1983-03-24 |
Most recent GEO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K844145 | Med-Tool, Inc. | GENERAL SURGICAL FILES | 1984-11-20 | 28 |
| K830675 | Unisplint Corp. | ORAL SPONGE | 1983-03-24 | 21 |
Recalls for GEO devices
openFDA lists no recalls for product code GEO.
Frequently asked questions
What is FDA product code GEO?
GEO is the FDA product code for file, surgical, 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 GEO?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GEO?
Across 2 cleared submissions the average was 24 days from receipt to decision (median 24).
Which companies have the most GEO clearances?
Med-Tool, Inc. (1); Unisplint Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GEO
- Run a recall and safety report across every GEO manufacturer
- Watch product code GEO 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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