# K151268: Spinaut-V, Spinaut-S, Spinaut-I

- Pathway: 510(k) (Traditional)
- Applicant: Imedicom Co., Ltd.
- Decided: Mar 16, 2016 after 308 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- 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 K954584 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980734: Myelotec Video Guided Catheter, Myelotec, Inc. (1998) Summary page 4.

## Indications for use
When used with a fiberoptic endoscope, SPINAUT-V can be used for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications. The SPINAUT-S is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease. SPINAUT-I is intended for the percutaneous introduction and placement of a video guided catheter and/or an endoscope.

Source page: https://510kreport.com/device/K151268
Methodology: https://510kreport.com/methodology