# K991636: Elekta Stereotactic Guide

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: Jul 20, 1999 after 69 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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 K851659 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955397: Mayfield-Acciss Workstation, Nomos Corp. (1996) Summary page 1.
- K830999: Dap II Biopsy Guide, Rapid Machine & Tool Corp. (1983) Summary page 1.
- K972324: Leksell Stereotactic System, Elekta Instrument AB (1998) Summary page 1.

## Indications for use
The Elekta Stereotactic Guide is indicated for use in guidance and stereotactic instrument positioning in open cranial procedures and surgeries normally performed with traditional stereotactic apparatus.

Source page: https://510kreport.com/device/K991636
Methodology: https://510kreport.com/methodology