# K091343: Mri Neuro Drape

- Pathway: 510(k) (Traditional)
- Applicant: Surgivision, Inc.
- Decided: Sep 22, 2009 after 139 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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 K931417 (1995). 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)
- K081476: Surgical Concept Designs Positionor Surgical Drape, Surgical Concept Designs (2008) Summary page 1.

## Indications for use
The MRI Neuro Surgical Drape is intended to provide a sterile, disposable covering of the MRI instrumentation during surgical procedures conducted under MRI imaging. The Device Number is 100. Accessories: Grommet, grommet tool and trackball cover.

Source page: https://510kreport.com/device/K091343
Methodology: https://510kreport.com/methodology