# K073678: Variosurg

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Jul 10, 2008 after 195 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K254163: VarioSurg 4 (2025), 0 descendants of its own

## Recalls of this device
- Jul 8, 2016 · Class II · Z-2673-2016: Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets suc

## Indications for use
The VarioSurg device is intended for bone cutting in oral surgery, scaling and root planing, and retrograde preparation of root canals.

Source page: https://510kreport.com/device/K073678
Methodology: https://510kreport.com/methodology