Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Clickfine Pen Needle, Penfine Classic Pen Needle

K-Number: K171984 · 2017-10-11

ApplicantYpsomed AG
Decision Date2017-10-11
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Clickfine Pen Needle, Penfine Classic Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is Ypsomed AG. It received FDA 510(k) clearance on 2017-10-11 under 510(k) number K171984. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clickfine Pen Needle, Penfine Classic Pen Needle?

Clickfine Pen Needle, Penfine Classic Pen Needle is a medical device that received FDA 510(k) clearance on 2017-10-11. The listed applicant is Ypsomed AG. The 510(k) number is K171984.

When did Clickfine Pen Needle, Penfine Classic Pen Needle receive FDA 510(k) clearance?

Clickfine Pen Needle, Penfine Classic Pen Needle received FDA 510(k) clearance on 2017-10-11, under 510(k) number K171984.

Who is the listed applicant for Clickfine Pen Needle, Penfine Classic Pen Needle?

The FDA 510(k) record lists Ypsomed AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clickfine Pen Needle, Penfine Classic Pen Needle?

The FDA product code for Clickfine Pen Needle, Penfine Classic Pen Needle is FMI.

Other records listing Ypsomed AG 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: FMI)

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.