FDA product code FYF: Cap, Surgical
FYF is the FDA product code for cap, 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 32 510(k) submissions under FYF, from 22 different applicants. The average 510(k) review took 50 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Cap, 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 FYF clearance
Top FYF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Amerasia Corp. | 3 | 1996-03-15 |
| Sherwood Medical Industries | 3 | 1977-03-07 |
| The Owenby Co. | 3 | 1976-12-30 |
| American Threshold Industries, Inc. | 2 | 1996-01-05 |
| A Plus International, Inc. | 2 | 1988-06-23 |
17 more applicants have FYF clearances. See the full list in Caduvo.
Most recent FYF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972227 | American Seal Co. | SHOE COVER | 1997-09-09 | 88 |
| K955833 | Amerasia Corp. | NIOMED SURGICAL CAPS | 1996-03-15 | 80 |
| K954556 | Thai Disposable Products Co., Ltd. | SURGICAL CAP | 1996-03-12 | 162 |
| K954455 | Amerasia Corp. | NIOMED BOUFFANT CAPS | 1996-01-23 | 120 |
| K954454 | Amerasia Corp. | NIOMED SURGICAL HOOD | 1996-01-23 | 120 |
Recalls for FYF devices
openFDA lists no recalls for product code FYF.
Frequently asked questions
What is FDA product code FYF?
FYF is the FDA product code for cap, 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 FYF?
Class I, regulation 21 CFR 878.4040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FYF?
Across 32 cleared submissions the average was 50 days from receipt to decision (median 32).
Which companies have the most FYF clearances?
Amerasia Corp. (3); Sherwood Medical Industries (3); The Owenby Co. (3); American Threshold Industries, Inc. (2); A Plus International, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code FYF
- Run a recall and safety report across every FYF manufacturer
- Watch product code FYF 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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