FDA product code FWW: Table, Operating-Room, Pneumatic
FWW is the FDA product code for table, operating-room, pneumatic. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under FWW, from 6 different applicants. The average 510(k) review took 110 days (median 119).
Classification
| Field | Value |
|---|---|
| Device name | Table, Operating-Room, Pneumatic |
| Device class | Class I |
| Regulation | 21 CFR 878.4960 |
| 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 FWW clearance
Top FWW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Osteonics Corp. | 1 | 1995-11-29 |
| Amsco American Sterilizer Co. | 1 | 1994-03-23 |
| Vvortex International Corp. | 1 | 1993-09-09 |
| T. Korossurgical Instruments Corp. | 1 | 1993-05-17 |
| Kamiya Tsusan Kaisha, Ltd. | 1 | 1986-09-05 |
1 more applicants have FWW clearances. See the full list in Caduvo.
Most recent FWW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953961 | Osteonics Corp. | OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM | 1995-11-29 | 99 |
| K935356 | Amsco American Sterilizer Co. | CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES | 1994-03-23 | 139 |
| K931876 | Vvortex International Corp. | FISK ARM SUPPORT | 1993-09-09 | 148 |
| K924713 | T. Korossurgical Instruments Corp. | UNIVERSAL SURGICAL INSTRUMENT HOLDER | 1993-05-17 | 241 |
| K863161 | Kamiya Tsusan Kaisha, Ltd. | TABLE, OPERATING ROOM, HYDRAULIC | 1986-09-05 | 18 |
Recalls for FWW devices
openFDA lists no recalls for product code FWW.
Frequently asked questions
What is FDA product code FWW?
FWW is the FDA product code for table, operating-room, pneumatic. It is a Class I device, regulated under 21 CFR 878.4960 and reviewed by the General and Plastic Surgery panel.
What device class is FWW?
Class I, regulation 21 CFR 878.4960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FWW?
Across 6 cleared submissions the average was 110 days from receipt to decision (median 119).
Which companies have the most FWW clearances?
Osteonics Corp. (1); Amsco American Sterilizer Co. (1); Vvortex International Corp. (1); T. Korossurgical Instruments Corp. (1); Kamiya Tsusan Kaisha, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FWW
- Run a recall and safety report across every FWW manufacturer
- Watch product code FWW 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