Cleared Special

Promisemed Safety Huber Needles

K243332 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital

Mar 2025

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K243332 is an FDA 510(k) clearance for the Promisemed Safety Huber Needles, a Non-coring (huber) Needle (Class II — Special Controls, product code PTI), submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on March 14, 2025, 141 days after receiving the submission on October 24, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K243332 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 2024
Decision Date	March 14, 2025
Days to Decision	141 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PTI — Non-coring (huber) Needle
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5570
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.