# K902818: Multiple Nonpowered Neurosurgical Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Ruggles Corp.
- Decided: Sep 20, 1990 after 85 days
- Product code: HBG (Drills, Burrs, Trephines & Accessories (Manual))
- Device class: 2
- Regulation: 21 CFR 882.4300
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 17, 2013 · Class II · Z-2056-2013: As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all 

Source page: https://510kreport.com/device/K902818
Methodology: https://510kreport.com/methodology