FDA product code GFG: Bit, Surgical
GFG is the FDA product code for bit, surgical. It is a Class I device, regulated under 21 CFR 878.4820 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under GFG, from 3 different applicants. The average 510(k) review took 74 days (median 44). FDA has posted 17 recalls for GFG devices.
Classification
| Field | Value |
|---|---|
| Device name | Bit, Surgical |
| 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 GFG clearance
Top GFG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mitek Surgical Products, Inc. | 1 | 1994-04-07 |
| Spire Medical, Inc. | 1 | 1982-06-09 |
| Key Medical, Inc. | 1 | 1982-06-03 |
Most recent GFG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935225 | Mitek Surgical Products, Inc. | MITEK MODULAR DRILL BIT | 1994-04-07 | 157 |
| K821486 | Spire Medical, Inc. | MICRO DRILLS | 1982-06-09 | 22 |
| K821127 | Key Medical, Inc. | KEY DRILL | 1982-06-03 | 44 |
Recalls for GFG devices
17 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-03-15.
| Year | Recalls |
|---|---|
| 2017 | 14 |
Frequently asked questions
What is FDA product code GFG?
GFG is the FDA product code for bit, surgical. 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 GFG?
Class I, regulation 21 CFR 878.4820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GFG?
Across 3 cleared submissions the average was 74 days from receipt to decision (median 44).
Which companies have the most GFG clearances?
Mitek Surgical Products, Inc. (1); Spire Medical, Inc. (1); Key Medical, Inc. (1).
Have GFG devices been recalled?
Yes: 17 product recalls across 4 recall events; the most recent began 2017-03-15.
Next steps
- Run an FDA pathway report with predicate devices for product code GFG
- Run a recall and safety report across every GFG manufacturer
- Watch product code GFG 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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