FDA product code FGY: Cannula, Injection
FGY is the FDA product code for cannula, injection. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under FGY, from 2 different applicants. The average 510(k) review took 82 days (median 82). FDA has posted 7 recalls for FGY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cannula, Injection |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| 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 FGY clearance
Top FGY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kelleher Corp. | 1 | 1982-10-06 |
| B. Braun Instruments | 1 | 1976-11-02 |
Most recent FGY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K822201 | Kelleher Corp. | EAR CANNULAS | 1982-10-06 | 75 |
| K760389 | B. Braun Instruments | CANNULA, IV | 1976-11-02 | 89 |
Recalls for FGY devices
7 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-07-29.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code FGY?
FGY is the FDA product code for cannula, injection. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is FGY?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FGY?
Across 2 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most FGY clearances?
Kelleher Corp. (1); B. Braun Instruments (1).
Have FGY devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2022-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code FGY
- Run a recall and safety report across every FGY manufacturer
- Watch product code FGY 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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