Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga— 510(k) K163537

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K163537 for Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga, Substantially Equivalent on 2017-04-21. Applicant: Covidien, LLC.

Clearance details

Applicant: Covidien, LLC
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2016-12-16
Decision date: 2017-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.