FC-78
The FDA summary names FC-78 as a wired foot control supplied with the VarioSurg 4 system. It describes the foot control as providing hands-free control of irrigation flow and program…
The FDA summary names FC-78 as a wired foot control supplied with the VarioSurg 4 system.
It describes the foot control as providing hands-free control of irrigation flow and program selection, and switching ultrasound on or off.
System Connection
FC-78 is listed as the wired foot control option. It is a system component alongside the control unit and ultrasonic handpiece. The comparison lists wired or wireless foot-control connectivity as system alternatives.
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Nakanishi Inc., Japan |
|---|---|
| FDA product code | DZI |
| Device type | Drill, Bone, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K254163 |
| Record published | 2026-04-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FC-78 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drill, Bone, Powered | Synthes Gmbh | 150 |
| Acteon | Satelec | 87 |
| Neoss Implant System | Neoss AB | 74 |
| Mectron | Mectron SPA | 48 |
| OneDrill Surgical Drill | Osseofuse International Inc. | 48 |
| Silfradent srl | Silfradent SRL | 45 |
| MatrixMANDIBLE | Synthes Gmbh | 31 |
| DIRECTguide™ Step Drill | Implant Direct Sybron Manufacturing LLC | 31 |
| DIRECTguide™ Guided Step Drill | Implant Direct Sybron Manufacturing LLC | 30 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 28 |
| VarioSurg | Nakanishi Inc. | 22 |
| Nobel Biocare® | Nobel Biocare AB | 20 |
Showing 12 of 265. All products under Drill, Bone, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254163 | 2025-12-23 |
| K073678 | 2008-07-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.