# K041897: Mayfield Acciss II Image Guided Surgery System, Model 2002-01

- Pathway: 510(k) (Traditional)
- Applicant: Schaerer Mayfield USA, Inc.
- Decided: Jun 1, 2005 after 322 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: 3 generations back to K954276 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013428: Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss System, Ohio Medical Instrument Co., Inc. (2002)
- K013419: Nicolet Electromagnetic Navigation System, Nicolet Biomedical (2001) Summary page 1.

## Indications for use
MAYFIELD® ACCISSTM II IMAGE GUIDED SURGERY SYSTEM is indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure such as the skull, a long bone, or vertebra can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.

Source page: https://510kreport.com/device/K041897
Methodology: https://510kreport.com/methodology