FDA product code FSE: Table, Operating-Room, Manual
FSE is the FDA product code for table, operating-room, manual. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel. FDA has cleared 13 510(k) submissions under FSE, from 11 different applicants. The average 510(k) review took 41 days (median 30). FDA has posted 1 recall for FSE devices.
Classification
| Field | Value |
|---|---|
| Device name | Table, Operating-Room, Manual |
| Device class | Class I |
| Regulation | 21 CFR 878.4950 |
| 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 FSE clearance
Top FSE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Devon Industries, Inc. | 3 | 1978-08-14 |
| Porex Medical | 1 | 1986-03-13 |
| Aspen Laboratories, Inc. | 1 | 1984-10-25 |
| Healthmate, Inc. | 1 | 1984-02-04 |
| Orthopedic Systems, Inc. | 1 | 1983-05-16 |
6 more applicants have FSE clearances. See the full list in Caduvo.
Most recent FSE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K860503 | Porex Medical | THE POREX RETRACTOR TABLE | 1986-03-13 | 30 |
| K843801 | Aspen Laboratories, Inc. | MASON EQUIPMENT ORGANIZER & ASPEN | 1984-10-25 | 28 |
| K840027 | Healthmate, Inc. | OPERATING ROOM STAND | 1984-02-04 | 30 |
| K831042 | Orthopedic Systems, Inc. | CHEMONUCLEOLYSIS TABLE EXTENSION | 1983-05-16 | 46 |
| K830339 | Intl. Management Services, Inc. | IMSI/METRIPOND HAND OPERATING TABLE | 1983-04-12 | 70 |
Recalls for FSE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-05-15.
Frequently asked questions
What is FDA product code FSE?
FSE is the FDA product code for table, operating-room, manual. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel.
What device class is FSE?
Class I, regulation 21 CFR 878.4950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSE?
Across 13 cleared submissions the average was 41 days from receipt to decision (median 30).
Which companies have the most FSE clearances?
Devon Industries, Inc. (3); Porex Medical (1); Aspen Laboratories, Inc. (1); Healthmate, Inc. (1); Orthopedic Systems, Inc. (1).
Have FSE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-05-15.
Next steps
- Run an FDA pathway report with predicate devices for product code FSE
- Run a recall and safety report across every FSE manufacturer
- Watch product code FSE 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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