FDA product code GFC: Driver, Surgical, Pin
GFC is the FDA product code for driver, surgical, pin. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under GFC, from 2 different applicants. The average 510(k) review took 48 days (median 48). FDA has posted 2 recalls for GFC devices.
Classification
| Field | Value |
|---|---|
| Device name | Driver, Surgical, Pin |
| Device class | Class I |
| Regulation | 21 CFR 878.4820 |
| 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 GFC clearance
Top GFC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Equipment Co., Inc. | 1 | 1978-09-27 |
| Scanlan Intl., Inc. | 1 | 1978-04-18 |
Most recent GFC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K781450 | Orthopedic Equipment Co., Inc. | DRIVERS | 1978-09-27 | 35 |
| K780255 | Scanlan Intl., Inc. | NEEDLE DRIVER | 1978-04-18 | 61 |
Recalls for GFC devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-09-09.
Frequently asked questions
What is FDA product code GFC?
GFC is the FDA product code for driver, surgical, pin. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel.
What device class is GFC?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GFC?
Across 2 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most GFC clearances?
Orthopedic Equipment Co., Inc. (1); Scanlan Intl., Inc. (1).
Have GFC devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2014-09-09.
Next steps
- Run an FDA pathway report with predicate devices for product code GFC
- Run a recall and safety report across every GFC manufacturer
- Watch product code GFC 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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