NIM4— 510(k) K982595

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K982595 for NIM4, Substantially Equivalent on 1998-09-04. Applicant: Xomed, Inc..

Clearance details

Applicant: Xomed, Inc.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 1998-07-27
Decision date: 1998-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

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.