# K110739: Entellus Medical Sinus Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Entellus Medical, Inc.
- Decided: Jun 14, 2011 after 89 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: 3 generations back to K011084 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033321: Selectiva SB Guidewire, Neometrics, Inc. (2003) Summary page 1.
- K013024: Selectiva Guidewire, Neometrics, Inc. (2001) Summary page 1.
- (no number) Relieva Vigor™ Sinus Guidewire: named in the summary without a submission number

## Indications for use
To provide a means to access the frontal, sphenoid and maxillary sinuses, for diagnostic and therapeutic procedures in adults aged 18 and over.

Source page: https://510kreport.com/device/K110739
Methodology: https://510kreport.com/methodology