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FDA 510(k)

Promisemed Triple Safety Pen Needle

K-Number: K202682 · 2020-11-24

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2020-11-24
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Promisemed Triple Safety Pen Needle is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2020-11-24 under approval number K202682. 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 Promisemed Triple Safety Pen Needle?

Promisemed Triple Safety Pen Needle is a medical device that received FDA 510(k) clearance on 2020-11-24. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K202682.

When was Promisemed Triple Safety Pen Needle approved by the FDA?

Promisemed Triple Safety Pen Needle received FDA 510(k) clearance on 2020-11-24, under approval number K202682.

What company makes Promisemed Triple Safety Pen Needle?

Promisemed Triple Safety Pen Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Promisemed Triple Safety Pen Needle?

The FDA product code for Promisemed Triple 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)

Other Devices by Promisemed Hangzhou Meditech Co., Ltd.

K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle K193009Promisemed Heel Blood Lancet K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K191853Dual-Safety Pen Needle K202681Promisemed Covered Safety Pen Needle K211890Promisemed Sharps container

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Related Devices (Code: FMI)

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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.

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