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FDA 510(k)

25G Huber Needle

K-Number: K254095 · 2026-09-18

ApplicantMartech Medical Products
Decision Date2026-09-18
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

25G Huber Needle is the device name listed in this FDA 510(k) record. The listed applicant is Martech Medical Products. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K254095. 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 25G Huber Needle?

25G Huber Needle is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Martech Medical Products. The 510(k) number is K254095.

When did 25G Huber Needle receive FDA 510(k) clearance?

25G Huber Needle received FDA 510(k) clearance on 2026-09-18, under 510(k) number K254095.

Who is the listed applicant for 25G Huber Needle?

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

What is the FDA product code for 25G Huber Needle?

The FDA product code for 25G Huber Needle is PTI.

Related Devices (Code: PTI)

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.

K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd.K241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetBard Access Systems, Inc.K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.K213823Intera Refill KitIntera Oncology, Inc.

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.

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