# K150915: Spinaut-P

- Pathway: 510(k) (Traditional)
- Applicant: Imedicom Co., Ltd.
- Decided: Mar 18, 2016 after 347 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010811 (2001). 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)
- K132099: Arthrocare Coblator IQ DLR Spinewand, Arthrocare Coblator IQ DLG Spinewand, ArthroCare Corporation (2013) Summary page 4.
- K132797: L'DISQ, U&I Corporation (2014) Summary page 4.

## Indications for use
The SPINUAT-P is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.

Source page: https://510kreport.com/device/K150915
Methodology: https://510kreport.com/methodology