FWW
6 FDA 510(k) clearances · Product code
139 daysmedian time to decision
241 days90th percentile
6clearances measured
FDA profile
- Official device name
- Table, Operating-Room, Pneumatic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4960
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1992: 2 · 1993: 1 · 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM (K953961) | Osteonics Corp. | 1995-11-29 |
| CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES (K935356) | Amsco American Sterilizer Co. | 1994-03-23 |
| FISK ARM SUPPORT (K931876) | Vvortex International Corp. | 1993-09-09 |
| UNIVERSAL SURGICAL INSTRUMENT HOLDER (K924713) | T. Korossurgical Instruments Corp. | 1993-05-17 |
| TABLE, OPERATING ROOM, HYDRAULIC (K863161) | Kamiya Tsusan Kaisha, Ltd. | 1986-09-05 |
| SKYTRON ELITE 300 SURGERY TABLE (K853479) | Skytron, Div. the Kmw Group, Inc. | 1985-09-05 |
Track FWW automatically
Every clearance here is in the API, with alerts when new ones post.