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PTI — Non-Coring (Huber) Needle Class II

FDA Device Classification

Classification Details

Product Code
PTI
Device Class
Class II
Regulation Number
880.5570
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

The non-coring needle (Huber) is utilized to gain access into a subcutaneous implanted intravascular infusion port but can also be used to access other non-vascular implanted devices with similar septums.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252355sb-kawasumi laboratoriesK-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingNovember 26, 2025
K251138promisemed hangzhou meditech coPromisemed Safety Huber NeedlesMay 13, 2025
K243332promisemed hangzhou meditech coPromisemed Safety Huber NeedlesMarch 14, 2025
K241353bard access systemsPowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetNovember 27, 2024
K230715promisemed hangzhou meditech coPromisemed Safety Huber NeedleJune 8, 2023
K213823intera oncologyIntera Refill KitMarch 16, 2022
K211121intera oncologyIntera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special boluOctober 14, 2021
K200463jiangsu caina medical coHuber Needle Infusion Set, Safety Huber Needle Infusion SetApril 7, 2021
K170881infusion safety productsISP Safety Huber Needle Infusion SetDecember 14, 2017
K170897b.braun medicalSurecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle witNovember 3, 2017
K171735c.r. bardPowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle SetAugust 8, 2017
K171333medcomp (dba medical components, inc.)20G x 5/8 Pro-Lock CT Safety Infusion SetJuly 18, 2017
K162271medcomp (medical components, inc.)Pro-Lock CT Safety Infusion SetApril 26, 2017