LITE-BLADE— 510(k) K944428

Substantially Equivalent

Eare Consulting Service

FDA 510(k) clearance K944428 for LITE-BLADE, Substantially Equivalent on 1994-11-15. Applicant: Eare Consulting Service.

Clearance details

Applicant: Eare Consulting Service
Product code: Code CCW
Advisory panel: Anesthesiology
Date received: 1994-09-12
Decision date: 1994-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eilat, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

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.