Promisemed Safety Huber Needles
K-Number: K243332 · 2025-03-14
Decision Date2025-03-14
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Promisemed Safety Huber Needles is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2025-03-14 under approval number K243332. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Promisemed Safety Huber Needles?
Promisemed Safety Huber Needles is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K243332.
When was Promisemed Safety Huber Needles approved by the FDA?
Promisemed Safety Huber Needles received FDA 510(k) clearance on 2025-03-14, under approval number K243332.
What company makes Promisemed Safety Huber Needles?
Promisemed Safety Huber Needles is manufactured by Promisemed Hangzhou Meditech Co., Ltd..
What is the FDA product code for Promisemed Safety Huber Needles?
The FDA product code for Promisemed Safety Huber Needles is PTI.
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Other Devices by Promisemed Hangzhou Meditech Co., Ltd.
K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
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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.