FDA product code FWX: Table, Operating-Room, Mechanical
FWX is the FDA product code for table, operating-room, mechanical. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under FWX, from 3 different applicants. The average 510(k) review took 30 days (median 21). FDA has posted 1 recall for FWX devices.
Classification
| Field | Value |
|---|---|
| Device name | Table, Operating-Room, Mechanical |
| 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 FWX clearance
Top FWX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alm Surgical Equipment, Inc. | 1 | 1988-10-13 |
| Surgi-Quip Inc.U | 1 | 1984-05-09 |
| Emerson-Sack-Warner Corp. | 1 | 1982-07-13 |
Most recent FWX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884019 | Alm Surgical Equipment, Inc. | ALM OPERATING TABLES | 1988-10-13 | 21 |
| K841116 | Surgi-Quip Inc.U | MOBILE OPHTHALMIC OPERATING TABLE | 1984-05-09 | 55 |
| K821923 | Emerson-Sack-Warner Corp. | TABLE, OPERATING, FIELD 6530-00-709-8175 | 1982-07-13 | 14 |
Recalls for FWX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-05-21.
Frequently asked questions
What is FDA product code FWX?
FWX is the FDA product code for table, operating-room, mechanical. 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 FWX?
Class I, regulation 21 CFR 878.4950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWX?
Across 3 cleared submissions the average was 30 days from receipt to decision (median 21).
Which companies have the most FWX clearances?
Alm Surgical Equipment, Inc. (1); Surgi-Quip Inc.U (1); Emerson-Sack-Warner Corp. (1).
Have FWX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-05-21.
Next steps
- Run an FDA pathway report with predicate devices for product code FWX
- Run a recall and safety report across every FWX manufacturer
- Watch product code FWX 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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