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FDA 510(k)

Promisemed Safety Huber Needles

K-Number: K251138 · 2025-05-13

ApplicantPromisemed Hangzhou Meditech Co., Ltd.
Decision Date2025-05-13
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 2025-05-13 under approval number K251138. 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 2025-05-13. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K251138.

When was Promisemed Safety Huber Needles approved by the FDA?

Promisemed Safety Huber Needles received FDA 510(k) clearance on 2025-05-13, under approval number K251138.

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 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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Related Devices (Code: PTI)

K170881ISP Safety Huber Needle Infusion SetInfusion Safety Products, Inc. K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y siteB.Braun Medical, Inc. K171735PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetC.R. Bard, Inc. K17133320G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.) K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) K211121Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep KitIntera Oncology, Inc.

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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