Monoject— 510(k) K161045

Substantially Equivalent

Covidien

FDA 510(k) clearance K161045 for Monoject, Substantially Equivalent on 2016-06-17. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code PNR
Advisory panel: Gastroenterology, Urology
Date received: 2016-04-13
Decision date: 2016-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PNR

product code PNR

Other: 6
Total: 6

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.