Monoject
K-Number: K161045 · 2016-06-17
Device Summary
Frequently Asked Questions
What is the Monoject?
Monoject is a medical device that received FDA 510(k) clearance on 2016-06-17. The listed applicant is Covidien. The 510(k) number is K161045.
When did Monoject receive FDA 510(k) clearance?
Monoject received FDA 510(k) clearance on 2016-06-17, under 510(k) number K161045.
Who is the listed applicant for Monoject?
The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Monoject?
The FDA product code for Monoject is PNR.
Other records listing Covidien as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: PNR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.