# K132721: Spiway Endonasal Access Guide

- Pathway: 510(k) (Traditional)
- Applicant: Spiway, LLC
- Decided: Jan 29, 2014 after 152 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) K-Splint: named in the summary without a submission number

## Most influential descendants
- K153686: SPIWay Endonasal Access Guide (2016), 2 descendants of its own
- K180141: SPIWay Endonasal Access Guide (2018), 1 descendant of its own
- K213153: SPIWay Endonasal Access Guide (2021), 0 descendants of its own

## Indications for use
The SPI Way Endonasal Access Guide is indicated for use in endoscopic sphenoid sinus and transsphenoidal surgery.

Source page: https://510kreport.com/device/K132721
Methodology: https://510kreport.com/methodology