FDA product code FXY: Hood, Surgical
FXY is the FDA product code for hood, surgical. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel. FDA has cleared 13 510(k) submissions under FXY, 1 in the last five years, from 9 different applicants. The average 510(k) review took 73 days (median 37). FDA has posted 3 recalls for FXY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Hood, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 878.4040 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FXY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 22 |
| 2023 | 1 | 449 |
Compare with all 510(k) review times · Search every FXY clearance
Top FXY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker Corporation | 2 | 2020-03-21 |
| Biomedical Devices, Inc. | 2 | 1990-10-19 |
| Sherwood Medical Industries | 2 | 1977-03-01 |
| Surgikos, Inc. | 2 | 1976-11-03 |
| Thi Total Healthcare Innovation GmbH | 1 | 2023-10-17 |
4 more applicants have FXY clearances. See the full list in Caduvo.
Most recent FXY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222214 | Thi Total Healthcare Innovation GmbH | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) | 2023-10-17 | 449 |
| K200493 | Stryker Corporation | Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover | 2020-03-21 | 22 |
| K140588 | Stryker Corporation | FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS | 2014-06-26 | 111 |
| K904969 | Chicago Assoc. For Retarded Citizens | HOOD, OPERATING, SURGICAL | 1990-12-12 | 37 |
| K904276 | Anago, Inc. | DISPOSABLE BEARD COVER | 1990-11-21 | 63 |
Recalls for FXY devices
3 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-20.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code FXY?
FXY is the FDA product code for hood, surgical. It is a Class II device, regulated under 21 CFR 878.4040 and reviewed by the General Hospital panel.
What device class is FXY?
Class II, regulation 21 CFR 878.4040. Typical premarket route: 510(k).
How long does a 510(k) take for product code FXY?
Across 13 cleared submissions the average was 73 days from receipt to decision (median 37).
Which companies have the most FXY clearances?
Stryker Corporation (2); Biomedical Devices, Inc. (2); Sherwood Medical Industries (2); Surgikos, Inc. (2); Thi Total Healthcare Innovation GmbH (1).
Have FXY devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2024-02-20.
Next steps
- Run an FDA pathway report with predicate devices for product code FXY
- Run a recall and safety report across every FXY manufacturer
- Watch product code FXY 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times