SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT— 510(k) K131709

Substantially Equivalent

Arthrocare Corp.

FDA 510(k) clearance K131709 for SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT, Substantially Equivalent on 2013-10-04. Applicant: Arthrocare Corp..

Clearance details

Applicant: Arthrocare Corp.
Product code: Code LRC
Advisory panel: Ear, Nose, Throat
Date received: 2013-06-11
Decision date: 2013-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRC

product code LRC

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.