NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long— 510(k) K213246

Substantially Equivalent

Medtronic Xomed, Inc.

FDA 510(k) clearance K213246 for NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long, Substantially Equivalent on 2022-03-21. Applicant: Medtronic Xomed, Inc..

Clearance details

Applicant: Medtronic Xomed, Inc.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2021-09-30
Decision date: 2022-03-21
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.