Verifine® Pen Needles
K-Number: K242632 · 2024-09-26
Decision Date2024-09-26
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Verifine® Pen Needles is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2024-09-26 under approval number K242632. 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 Verifine® Pen Needles?
Verifine® Pen Needles is a medical device that received FDA 510(k) clearance on 2024-09-26. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K242632.
When was Verifine® Pen Needles approved by the FDA?
Verifine® Pen Needles received FDA 510(k) clearance on 2024-09-26, under approval number K242632.
What company makes Verifine® Pen Needles?
Verifine® Pen Needles is manufactured by Promisemed Hangzhou Meditech Co., Ltd..
What is the FDA product code for Verifine® Pen Needles?
The FDA product code for Verifine® Pen Needles is FMI.
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
K202682Promisemed Triple Safety Pen Needle
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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.