FDA product code FYE: Dress, Surgical
FYE is the FDA product code for dress, surgical. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under FYE, from 7 different applicants. The average 510(k) review took 88 days (median 64). FDA has posted 1 recall for FYE devices.
Classification
| Field | Value |
|---|---|
| Device name | Dress, Surgical |
| Device class | Class I |
| Regulation | 21 CFR 878.4040 |
| 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 FYE clearance
Top FYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Johnson & Johnson Medical, Inc. | 1 | 1994-04-11 |
| Unicor Federal Dept. of Justice | 1 | 1991-09-19 |
| Intermedics Orthopedics | 1 | 1991-05-15 |
| Depuy-Raynham | 1 | 1991-05-09 |
| Clinitech, Inc. | 1 | 1989-10-13 |
2 more applicants have FYE clearances. See the full list in Caduvo.
Most recent FYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932731 | Johnson & Johnson Medical, Inc. | BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN | 1994-04-11 | 308 |
| K912790 | Unicor Federal Dept. of Justice | SURGICAL GOWN | 1991-09-19 | 86 |
| K910920 | Intermedics Orthopedics | PROTEKT GLOVES | 1991-05-15 | 71 |
| K910941 | Depuy-Raynham | LIFELINER SURGICAL GLOVE | 1991-05-09 | 64 |
| K895667 | Clinitech, Inc. | STERILE SURGICAL GOWN | 1989-10-13 | 23 |
Recalls for FYE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-05-08.
Frequently asked questions
What is FDA product code FYE?
FYE is the FDA product code for dress, surgical. It is a Class I device, regulated under 21 CFR 878.4040 and reviewed by the General and Plastic Surgery panel.
What device class is FYE?
Class I, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FYE?
Across 7 cleared submissions the average was 88 days from receipt to decision (median 64).
Which companies have the most FYE clearances?
Johnson & Johnson Medical, Inc. (1); Unicor Federal Dept. of Justice (1); Intermedics Orthopedics (1); Depuy-Raynham (1); Clinitech, Inc. (1).
Have FYE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-05-08.
Next steps
- Run an FDA pathway report with predicate devices for product code FYE
- Run a recall and safety report across every FYE manufacturer
- Watch product code FYE 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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