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FDA PRODUCT CODE · CLASS II

PTI — Non-Coring (Huber) Needle

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5570
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K252355Sb-Kawasumi Laboratories, Inc. · 510k2025-11-26
K251138Promisemed Hangzhou Meditech Co., Ltd. · 510k2025-05-13
K243332Promisemed Hangzhou Meditech Co., Ltd. · 510k2025-03-14
K241353Bard Access Systems, Inc. · 510k2024-11-27

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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