FDA product code FYI: Appliance, Facial Fracture, External
FYI is the FDA product code for appliance, facial fracture, external. It is a Class I device, regulated under 21 CFR 878.3250 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under FYI, from 4 different applicants. The average 510(k) review took 129 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Appliance, Facial Fracture, External |
| Device class | Class I |
| Regulation | 21 CFR 878.3250 |
| 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 FYI clearance
Top FYI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Omega Silicone, Inc. | 1 | 1987-05-11 |
| ETHICON, Inc. | 1 | 1983-06-11 |
| Surgical Technology Laboratories, Inc. | 1 | 1980-06-17 |
| Conphar, Inc. | 1 | 1979-11-05 |
Most recent FYI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871073 | Omega Silicone, Inc. | OMEGA BIVALVE NASAL SPLINTS | 1987-05-11 | 54 |
| K821178 | ETHICON, Inc. | ETHICON EXTERNAL FIXATION WIRE | 1983-06-11 | 410 |
| K801072 | Surgical Technology Laboratories, Inc. | STRAITH NASAL SPLINT | 1980-06-17 | 42 |
| K792106 | Conphar, Inc. | CONPHAR O.R. HEAD COVER-STERILE | 1979-11-05 | 11 |
Recalls for FYI devices
openFDA lists no recalls for product code FYI.
Frequently asked questions
What is FDA product code FYI?
FYI is the FDA product code for appliance, facial fracture, external. It is a Class I device, regulated under 21 CFR 878.3250 and reviewed by the General and Plastic Surgery panel.
What device class is FYI?
Class I, regulation 21 CFR 878.3250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FYI?
Across 4 cleared submissions the average was 129 days from receipt to decision (median 48).
Which companies have the most FYI clearances?
Omega Silicone, Inc. (1); ETHICON, Inc. (1); Surgical Technology Laboratories, Inc. (1); Conphar, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FYI
- Run a recall and safety report across every FYI manufacturer
- Watch product code FYI 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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