FDA product code GEF: Applier, Staple, Surgical,
GEF is the FDA product code for applier, staple, surgical,. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under GEF, from 4 different applicants. The average 510(k) review took 62 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Applier, Staple, Surgical, |
| 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 GEF clearance
Top GEF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Richard-Allan Medical | 1 | 1993-11-23 |
| Microaire | 1 | 1992-03-18 |
| American V. Mueller | 1 | 1985-12-02 |
| 3M Company | 1 | 1983-01-09 |
Most recent GEF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933508 | Richard-Allan Medical | REFLEX SDD SURGICAL STAPLER | 1993-11-23 | 126 |
| K915670 | Microaire | MICROAIRE MODEL 2600 | 1992-03-18 | 90 |
| K854568 | American V. Mueller | V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP | 1985-12-02 | 18 |
| K823888 | 3M Company | 3M FRASCIA STAPLING SYSTEM | 1983-01-09 | 13 |
Recalls for GEF devices
openFDA lists no recalls for product code GEF.
Frequently asked questions
What is FDA product code GEF?
GEF is the FDA product code for applier, staple, surgical,. 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 GEF?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GEF?
Across 4 cleared submissions the average was 62 days from receipt to decision (median 54).
Which companies have the most GEF clearances?
Richard-Allan Medical (1); Microaire (1); American V. Mueller (1); 3M Company (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GEF
- Run a recall and safety report across every GEF manufacturer
- Watch product code GEF 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times