# K131709: Sinus Dilation System with Cannulated Instrument

- Pathway: 510(k) (Special)
- Applicant: Arthrocare Corp.
- Decided: Oct 4, 2013 after 115 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: 15 generations back to K936109 (1994). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121351: Sinus Dilation System, Entrigue Surgical, Inc. (2012) Summary page 1.

## Indications for use
The Sinus Dilation System with Cannulated Instrument is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a transnasal approach.

Source page: https://510kreport.com/device/K131709
Methodology: https://510kreport.com/methodology