FDA 510(k)

EasyTouch Safety Pen Needle

K-Number: K163578 · 2018-08-03

Decision Date2018-08-03

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

EasyTouch Safety Pen Needle is a medical device manufactured by Mhc Medical Products, LLC. It received FDA 510(k) clearance on 2018-08-03 under approval number K163578. 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 EasyTouch Safety Pen Needle?

EasyTouch Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by Mhc Medical Products, LLC. The 510(k) number is K163578.

When was EasyTouch Safety Pen Needle approved by the FDA?

EasyTouch Safety Pen Needle received FDA 510(k) clearance on 2018-08-03, under approval number K163578.

What company makes EasyTouch Safety Pen Needle?

EasyTouch Safety Pen Needle is manufactured by Mhc Medical Products, LLC.

What is the FDA product code for EasyTouch Safety Pen Needle?

The FDA product code for EasyTouch Safety Pen Needle is FMI.

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.