# K152121: NuVent EM Sinus Dilation System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Dec 1, 2015 after 124 days
- Product code: LRC (Instrument, Ent Manual Surgical)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K936109 (1994). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132297: EM Sinus Dilation System, Medtronic Xomed, Inc. (2013) Summary page 4.

## Indications for use
The EM Sinus Dilation System is intended for use in conjunction with the Medtronic Computer-Assisted Surgery System during sinus procedures when surgical navigation or image-guided surgery may be necessary. When used concomitantly, these systems may be used to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia; or locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically altered to facilitate dilation of the sinus ostia. The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy. The system and its associated applications should be used only as an adjunct for surgical guidance. They do not replace the surgeon's knowledge, expertise, or judgment.

Source page: https://510kreport.com/device/K152121
Methodology: https://510kreport.com/methodology