FDA product code GEG: Elevator, Surgical, General & Plastic Surgery
GEG is the FDA product code for elevator, 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 12 510(k) submissions under GEG, from 9 different applicants. The average 510(k) review took 21 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Elevator, 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 GEG clearance
Top GEG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kinetic Medical Products | 3 | 1989-02-03 |
| Zinnanti Surgical Instruments, Inc. | 2 | 1989-04-12 |
| Micro-Aire Surgical Instruments, Inc. | 1 | 1987-07-16 |
| Buckman Co., Inc. | 1 | 1987-03-09 |
| Military Engineering, Inc. | 1 | 1987-02-26 |
4 more applicants have GEG clearances. See the full list in Caduvo.
Most recent GEG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891894 | Zinnanti Surgical Instruments, Inc. | ELEVATORS-COTTLE,MCKENTY,GOLDMAN,JOSEPH,CONVERSE | 1989-04-12 | 19 |
| K891899 | Zinnanti Surgical Instruments, Inc. | ELEVATORS, VARIOUS TYPES | 1989-04-12 | 19 |
| K890365 | Kinetic Medical Products | SEPTUM ELEVATOR | 1989-02-03 | 11 |
| K890253 | Kinetic Medical Products | SURGICAL ELEVATOR | 1989-01-27 | 9 |
| K890230 | Kinetic Medical Products | LIGATURE NEEDLES | 1989-01-27 | 9 |
Recalls for GEG devices
openFDA lists no recalls for product code GEG.
Frequently asked questions
What is FDA product code GEG?
GEG is the FDA product code for elevator, 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 GEG?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GEG?
Across 12 cleared submissions the average was 21 days from receipt to decision (median 18).
Which companies have the most GEG clearances?
Kinetic Medical Products (3); Zinnanti Surgical Instruments, Inc. (2); Micro-Aire Surgical Instruments, Inc. (1); Buckman Co., Inc. (1); Military Engineering, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GEG
- Run a recall and safety report across every GEG manufacturer
- Watch product code GEG 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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