FDA product code FWY: Table, Operating-Room, Non-Electrical
FWY is the FDA product code for table, operating-room, non-electrical. It is a Class I device, regulated under 21 CFR 878.4950 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under FWY, from 4 different applicants. The average 510(k) review took 28 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Table, Operating-Room, Non-Electrical |
| 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 FWY clearance
Top FWY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthopedic Systems, Inc. | 1 | 1988-08-26 |
| Skytron, Div. the Kmw Group, Inc. | 1 | 1987-09-24 |
| Stryker Corp. | 1 | 1983-11-28 |
| Warner-Lambert Co. | 1 | 1980-02-05 |
Most recent FWY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883457 | Orthopedic Systems, Inc. | ASST-3000 SPINAL SURGERY TABLE | 1988-08-26 | 14 |
| K873478 | Skytron, Div. the Kmw Group, Inc. | SKYTRON MODEL 130 SURGICAL TABLE | 1987-09-24 | 31 |
| K833509 | Stryker Corp. | CHEMONUCLEOLYSIS TABLE | 1983-11-28 | 48 |
| K800118 | Warner-Lambert Co. | CHICK SURGICAL TABLE | 1980-02-05 | 18 |
Recalls for FWY devices
openFDA lists no recalls for product code FWY.
Frequently asked questions
What is FDA product code FWY?
FWY is the FDA product code for table, operating-room, non-electrical. 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 FWY?
Class I, regulation 21 CFR 878.4950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWY?
Across 4 cleared submissions the average was 28 days from receipt to decision (median 24).
Which companies have the most FWY clearances?
Orthopedic Systems, Inc. (1); Skytron, Div. the Kmw Group, Inc. (1); Stryker Corp. (1); Warner-Lambert Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FWY
- Run a recall and safety report across every FWY manufacturer
- Watch product code FWY 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 and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times