SINUS DILATION SYSTEM— 510(k) K121351

Substantially Equivalent

Entrigue Surgical, Inc.

FDA 510(k) clearance K121351 for SINUS DILATION SYSTEM, Substantially Equivalent on 2012-08-29. Applicant: Entrigue Surgical, Inc..

Clearance details

Applicant: Entrigue Surgical, Inc.
Product code: Code LRC
Advisory panel: Ear, Nose, Throat
Date received: 2012-05-04
Decision date: 2012-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, 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.