# K213153: SPIWay Endonasal Access Guide

- Pathway: 510(k) (Special)
- Applicant: Spiway, LLC
- Decided: Oct 27, 2021 after 29 days
- Product code: LYA (Splint, Intranasal Septal)
- Device class: 1
- Regulation: 21 CFR 874.4780
- 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 K132721 (2014). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180141: SPIWay Endonasal Access Guide, Spiway, LLC (2018) Summary page 4.

## Indications for use
The SPIWay Endonasal Access Guide is indicated for use in endoscopic transnasal sphenoid sinus and skull base surgery.

Source page: https://510kreport.com/device/K213153
Methodology: https://510kreport.com/methodology