FDA product code GFJ: Mallet, Surgical, General & Plastic Surgery
GFJ is the FDA product code for mallet, 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 3 510(k) submissions under GFJ, from 3 different applicants. The average 510(k) review took 53 days (median 56). FDA has posted 2 recalls for GFJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Mallet, 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 GFJ clearance
Top GFJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-06-20 |
| Rabar, Inc. | 1 | 1984-11-30 |
| Kelleher Corp. | 1 | 1982-09-17 |
Most recent GFJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851789 | Artiberia | 29-200 TO 29-230 VARIOUS BONE MALLETS(WIHIGER, DOY | 1985-06-20 | 56 |
| K844017 | Rabar, Inc. | MICROTENS 7757 T.E.N.S. STIMULATOR | 1984-11-30 | 46 |
| K822204 | Kelleher Corp. | ENT MALLETS | 1982-09-17 | 56 |
Recalls for GFJ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-11-11.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code GFJ?
GFJ is the FDA product code for mallet, 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 GFJ?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GFJ?
Across 3 cleared submissions the average was 53 days from receipt to decision (median 56).
Which companies have the most GFJ clearances?
Artiberia (1); Rabar, Inc. (1); Kelleher Corp. (1).
Have GFJ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2019-11-11.
Next steps
- Run an FDA pathway report with predicate devices for product code GFJ
- Run a recall and safety report across every GFJ manufacturer
- Watch product code GFJ 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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