ACCLARENT SE Inflation Device— 510(k) K150172

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K150172 for ACCLARENT SE Inflation Device, Substantially Equivalent on 2015-04-07. Applicant: Acclarent, Inc..

Clearance details

Applicant: Acclarent, Inc.
Product code: Code LRC
Advisory panel: Ear, Nose, Throat
Date received: 2015-01-26
Decision date: 2015-04-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Rmenlo Park, CA, 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.