Cleared Traditional

Promisemed Safety Huber Needle

K230715 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital

Jun 2023

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K230715 is an FDA 510(k) clearance for the Promisemed Safety Huber Needle, 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 June 8, 2023, 85 days after receiving the submission on March 15, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K230715 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2023
Decision Date	June 08, 2023
Days to Decision	85 days
Submission Type	Traditional
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.