Mapping Suction Probe— 510(k) K212164

Substantially Equivalent

Inomed Medizintechnik GmbH

FDA 510(k) clearance K212164 for Mapping Suction Probe, Substantially Equivalent on 2022-11-11. Applicant: Inomed Medizintechnik GmbH.

Clearance details

Applicant: Inomed Medizintechnik GmbH
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2021-07-12
Decision date: 2022-11-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emmendingen, DE

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.