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Promisemed Safety Huber Needles

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251138

by Promisemed Hangzhou Meditech Co., Ltd.

Identifiers

510(k) Number
K251138 FDA 510(k)
FDA Product Code
PTI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Promisemed Safety Huber Needles are non-coring needles designed for use with implanted vascular ports. These devices facilitate access to the port system, allowing for the infusion of fluids or medications.

This device is regulated under FDA 510(k) clearance K251138. It is intended for clinical use in a general hospital setting, with specific configurations available including various needle lengths and non-lubricated options.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Promisemed, Insulin Pen Needles Manufacturer | Promisemed, PDF May 13, 2025 Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang ..., Promisemed Safety Huber Needle (K230715) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Promisemed Hangzhou Meditech Co., Ltd.

Sources (1)

  • FDA 510(k) K251138 24 fields · synced Oct 6, 2026