# K993851: Sodem Perforator Drive

- Pathway: 510(k) (Traditional)
- Applicant: Sodemsystems
- Decided: Dec 27, 1999 after 45 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K831756 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935567: Sodem Power System, Sodemsystems (1994) Summary page 1.
- K954717: Sodem High Speed System for Neurosurgery & Median Sternotomy, Sodem Diffusion SA (1997) Summary page 1.

## Indications for use
The Sodem Perforator Drive is intended for use in nenrosirgery.

Source page: https://510kreport.com/device/K993851
Methodology: https://510kreport.com/methodology