SURGICAL STIMULATORS— 510(k) K110422

Substantially Equivalent

Technomed Europe

FDA 510(k) clearance K110422 for SURGICAL STIMULATORS, Substantially Equivalent on 2011-05-26. Applicant: Technomed Europe.

Clearance details

Applicant: Technomed Europe
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2011-02-14
Decision date: 2011-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maastricht-Airport, NL

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.