510(k) K062549— XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238

Substantially Equivalent

Excel Tech. , Ltd.

Clearance details

Applicant: Excel Tech. , Ltd.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2006-08-30
Decision date: 2006-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

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.